medical device engineer

CommonSpirit Health

<div>Job Summary and Responsibilities<div> 
The CE Medical Device Network Engineer II will use the latest technology and testing analysis activities to ensure security measures are implemented throughout the entire medical device life cycle. They will successfully integrate medical device security systems and tools with the existing environment. In addition, this role partners with other Clinical Engineering technicians within the region to complete medical device related work efforts and projects that are of medium to high complexity. The Clinical Engineering (CE) Medical Device Network Engineer II works in conjunction with the Clinical Engineering Medical Device Security (CE MDS) Team for the development and implementation of remediation documentation. They have joint responsibility for maintaining and enhancing the security posture for CommonSpirit Health's medical devices, networks and information. Additionally they work directly with vendors to manage device vulnerabilities. They are jointly responsible for design, implementation and support of the Clinical Engineering IT environment. They will design, develop, configure and implement solutions to resolve technical and business issues of medium to high complexity related to medical device security. This position provides specialized repair (Radiology, Clinical Engineering and Clinical Engineering network devices) and maintenance services to medical treatment and diagnostic equipment.</div><div></div><div> 
Essential Functions</div><ul><li>
All associated Job responsibilities of the Clinical Engineering Medical Device Network Engineer I.</li><li>
Collaborate with cross-functional teams to architect solutions that strengthen security controls of network connected medical devices without disrupting device integrity or patient safety (e.g. network architecture, active directory, group policies, windows images, end point security tools, etc.)</li><li>
Tests configurations and deploys risk mitigation strategies in known and some unknown environments.</li><li>
Prepares, documents and presents detailed guidance for system configuration and risk mitigation.</li><li>
Detects, identifies and resolves vulnerabilities in devices or systems.</li><li>
Maintains thorough documentation and completes backups.</li><li>
Resolves technical challenges and provides support to field technicians utilizing innovative solutions.</li><li>
Troubleshoot and assist with recovery of medical devices due to issues associated with upgrades, patching, security vulnerabilities, threats, etc. Collaborates with the MDS team for the development and implementation of security remediation solutions associated with medical devices within the assigned region.</li><li>
Collaborates with vendors to manage device cyber vulnerabilities</li><li>
Coordinate efforts for medical device patching and updating firmware and/or applications appropriate for the medical device.</li><li>
Research medical device manufacturer's resources for approved patches and updates applicable to medical devices in all modalities</li></ul><div>
The job summary and responsibilities listed above are designed to indicate the general nature of the work performed within this job. They are not designed to contain or be interpreted as a comprehensive inventory of all job responsibilities required of employees assigned to this job. Employees may be required to perform other duties as assigned.</div> 
Job Requirements<div> 
Required:</div><ul><li>
Bachelors in HTM, Computer Science, Technology, Business disciple upon hire, or equivalent professional experience required</li><li>
Minimum of 5-6 Years in Clinical Engineering Networking Role or equivalent experience.</li><li>
Experience with HIPAA/HITECH compliance standards.
</li><li>Valid Drivers License</li></ul><div></div><div> 
Preferred:</div><ul><li>
Experience working with the software development life cycle or project management methodologies in addition to Customer Service related experience.</li></ul><div>
This position requires participation in a rotational on-call schedule, including nights, weekends, and holidays. Candidates must be available to respond to urgent service needs outside of regular business hours and may be required to return to the facility on short notice.</div>
Where You'll Work<div> 
Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation&rsquo;s largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 137 hospital-based locations, in addition to its home-based services and virtual care offerings. CommonSpirit has more than 157,000 employees, 45,000 nurses and 25,000 physicians and advanced practice providers across 24 states and contributes more than $4.2 billion annually in charity care, community benefits and unreimbursed government programs. Together with our patients, physicians, partners, and communities, we are creating a more just, equitable, and innovative healthcare delivery system.</div> 
Pay Range 
$49.78 - $74.05 /hour</div>

Clinical Engineering Medical Device Security Engineer II

<div>Job Summary and Responsibilities<div> 
The Clinical Engineering Med Device Security Eng I mitigates medical device vulnerabilities and threats at a system level by developing and testing remediation instructions, and partnering with cross-functional teams to implement mitigation strategies. In the event of a security incident, this position leads remediation efforts and coordinates with cross-functional teams to return medical devices to service and to implement measures that will prevent future attacks.</div><div></div><div> 
The Clinical Engineering Med Device Security Eng I has system level responsibilities to safeguard CommonSpirit's medical device environment to ensure device integrity and resilience by assessing, monitoring and responding to security vulnerabilities and threats. This role ensures that medical devices comply with relevant cybersecurity regulations, standards and guidelines.</div><div></div><div> 
Essential Function</div><ul><li>
Collaborate with cross-functional teams to implement mitigation strategies that address medical device security vulnerabilities and threats.</li><li>
Develop and test medical device security patching and remediation instructions to mitigate risks while also maintaining the integrity of the devices to ensure device reliability and patient safety.</li><li>
In the event of a security incident, lead system wide remediation efforts by coordinating with cross-functional teams to return the devices to service and to implement measures that will prevent future attacks.</li><li>
Conduct comprehensive assessments of system wide medical devices to identify potential security risks and vulnerabilities by reviewing MDS2 forms, and obtaining information from medical device OEMs.</li><li>
Ensure that medical devices comply with relevant cybersecurity regulations, standards and guidelines.</li><li>
Resolve technical challenges and provide support to field technicians.</li></ul><div>
The job summary and responsibilities listed above are designed to indicate the general nature of the work performed within this job. They are not designed to contain or be interpreted as a comprehensive inventory of all job responsibilities required of employees assigned to this job. Employees may be required to perform other duties as assigned.</div><div></div> 
Job Requirements<div> 
Required:</div><ul><li>
Bachelors Other HTM, Computer Science, Technology, Business disciple upon hire or equivalent professional experience required</li><li>
2-4 years experience working in healthcare/IT Security, System Administration, Software Development or related field.</li><li>
1-2 years experience working in a healthcare/medical environment</li><li>
Experience working with specialized medical equipment in a healthcare setting.</li><li>
Experience with Cybersecurity and Infrastructure Security Agency (CISA), HIPAA/HITECH compliance standards.</li><li>
Valid Drivers License</li></ul><div>
Preferred:</div><ul><li>
Experience working with the software development life cycle or project management methodologies.</li></ul><div>
This position requires participation in a rotational on-call schedule, including nights, weekends, and holidays. Candidates must be available to respond to urgent service needs outside of regular business hours and may be required to return to the facility on short notice.</div><div> 
</div>Where You'll Work<div> 
Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation&rsquo;s largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 137 hospital-based locations, in addition to its home-based services and virtual care offerings. CommonSpirit has more than 157,000 employees, 45,000 nurses and 25,000 physicians and advanced practice providers across 24 states and contributes more than $4.2 billion annually in charity care, community benefits and unreimbursed government programs. Together with our patients, physicians, partners, and communities, we are creating a more just, equitable, and innovative healthcare delivery system.</div> 
Pay Range 
$45.26 - $67.32 /hour</div>

Clinical Engineering Medical Device Security Engineer

Baptist Health System KY & IN

<div>Summary
Job Description:
BHMG Cardiology Lexington
The Clinical Device Coordinator is a patient educator, care coordinator, system navigator, and patient advocate with the mission to improve the cardiac experience for device patients at Baptist Health. The Clinical Device Coordinator works collaboratively with the patient and their support system, referring physicians and staff, cardiologists, EP Nurse Navigator, and other healthcare professionals to support the cardiac device patient through diagnosis and treatment. Provides professional clinical management of device patients under the direction of Electrophysiology Physicians.
MINIMUM QUALIFICATIONS:
<ul><li>Associate degree or higher in nursing required
</li><li>Current unrestricted Kentucky or compact state license as a Registered Nurse OR licensed in the state of practice or Cardiac Specialist Certificate via Arrythmia Technologies Institute (ATI) OR certified vendor training (Abbott, Biotronik, Boston Scientific, Medtronic)
</li><li>At least 3 years of cardiology experience.
</li><li>Basic Life Support (BLS) via the American Heart Association within 90 days of hire and other advanced training as appropriate.
</li></ul>BENEFITS INCLUDE:
<ul><li>Medical, Vision and Dental Insurance
</li><li>Competitive PTO Package
</li><li>401K Retirement Match
</li><li>Tuition Reimbursement
</li><li>Maternity/Paternity Leave
</li></ul>Work Experience
Education
<h3 class="jobSectionHeader">If you would like to be part of a growing family focused on supporting clinical excellence, teamwork and innovation, we urge you to apply now!
</h3><h3 class="jobSectionHeader">Baptist Health is an Equal Employment Opportunity employer.</h3></div>

Clinical Device Coordinator

Hippocratic AI

<div>
 
 About Us
 
 
 
 Hippocratic AI is the leading generative AI company in healthcare. We have the only system that can have safe, autonomous, clinical conversations with patients. We have trained our own LLMs as part of our Polaris constellation, resulting in a system with over 99.9% accuracy.
 
 
 
 Why Join Our Team
 
 
 
 
 Reinvent healthcare with AI that puts safety first.
 
 We&rsquo;re building the world&rsquo;s first healthcare‑only, safety‑focused LLM &mdash; a breakthrough platform designed to transform patient outcomes at a global scale. This is category creation.
 
 
 
 Work with the people shaping the future.
 
 Hippocratic AI was co‑founded by CEO Munjal Shah and a team of physicians, hospital leaders, AI pioneers, and researchers from institutions like El Camino Health, Johns Hopkins, Washington University in St. Louis, Stanford, Google, Meta, Microsoft, and NVIDIA.
 
 
 
 Backed by the world&rsquo;s leading healthcare and AI investors.
 
 We recently raised a $126M Series C at a $3.5B valuation, led by Avenir Growth, bringing total funding to $404M with participation from CapitalG, General Catalyst, a16z, Kleiner Perkins, Premji Invest, UHS, Cincinnati Children&rsquo;s, WellSpan Health, John Doerr, Rick Klausner, and others.
 
 
 
 Build alongside the best in healthcare and AI.
 
 Join experts who&rsquo;ve spent their careers improving care, advancing science, and building world‑changing technologies &mdash; ensuring our platform is powerful, trusted, and truly transformative.
 
 
 
 Location Requirement
 
 
 
 We believe the best ideas happen together. To support fast collaboration and a strong team culture, this role is expected to be in our Palo Alto office five days a week, unless otherwise specified.
 
 
 
 About The Role
 
 
 
 
 Vertical Ownership &amp; Solution Strategy
 
 
 
 Own the medtech vertical end-to-end &mdash; from market positioning and pipeline generation through solution design, enterprise sales, deployment, and account expansion. You are the single-threaded leader responsible for how Hippocratic AI wins in medical devices.
 
 
 Define and execute the AI-powered solution roadmap across the full device lifecycle: pre-surgical education, surgical scheduling, post-op recovery, implant tracking, patient onboarding, HCP training, field support, complaint handling, clinical evidence generation, and post-market surveillance. This isn't a strategy-only role &mdash; you are accountable for translating this roadmap into revenue.
 
 
 Develop systems-level solution architectures that reflect how AI agents interact with complex stakeholders (surgeons, clinical staff, field teams, quality and regulatory leaders) in high-pressure, real-world clinical and commercial environments.
 
 
 Prioritize ruthlessly based on the intersection of market demand, revenue potential, and deployment feasibility &mdash; ensuring the highest-impact solutions move first and the team isn't spread thin on low-signal opportunities.
 
 
 
 Commercial Leadership &amp; Revenue Accountability
 
 
 
 Serve as the primary external face of Hippocratic AI in medtech. You are the credible authority in enterprise sales conversations, C-suite workshops, industry conferences, and strategic partnerships &mdash; not a support function behind a seller, but the person in the room closing.
 
 
 Own the medtech go-to-market motion: positioning, messaging, target account strategy, pipeline development, and deal progression. Partner with marketing to build category-defining content, event strategy, and demand generation programs that reflect deep domain credibility rather than generic AI hype.
 
 
 Drive enterprise deal velocity by partnering directly with device company executives across commercial, quality, regulatory, and clinical functions to validate use cases, structure pilots, and build the trust required to move from evaluation to full-scale platform adoption.
 
 
 Build and own the economic narrative. Translate AI capabilities into hard-hitting ROI frameworks and financial models &mdash; reduced call center load, improved patient compliance, accelerated surgeon onboarding, lower complication-related costs &mdash; that resonate with CFOs and operating committees, not just innovation teams.
 
 
 
 Cross-Functional Execution &amp; Delivery
 
 
 
 Act as the bridge between clinical necessity and technical execution. Translate surgical workflows, field operations realities, and regulatory constraints into precise requirements, conversation designs, and acceptance criteria for Engineering and Product.
 
 
 Collaborate with Medical Affairs and Quality to ensure every AI solution meets stringent FDA post-market requirements, MDR/IVDR obligations, and promotion-compliance standards. You don't hand this off &mdash; you understand it well enough to make real-time judgment calls.
 
 
 Partner with Customer Success to define the deployment standard for medtech &mdash; creating readiness playbooks, implementation checklists, and go-live protocols that ensure zero-friction launches in live clinical settings. Own customer
 
 outcomes
 
 post-deployment, not just pre-sale enthusiasm.
 
 
 
 Market Intelligence, Enablement &amp; Team Building
 
 
 
 Build and maintain the internal source of truth for medtech &mdash; covering surgical adoption cycles, hospital and ASC procurement dynamics, GPO contracting, value-based models, and competitive landscape.
 
 
 Raise the medtech IQ of the entire organization. Develop training materials and internal enablement programs that allow cross-functional teams to engage credibly with surgeons, device manufacturers, and health system procurement leaders.
 
 
 Proactively identify ecosystem shifts &mdash; Hospital-at-Home, ASC growth, remote patient monitoring, connected devices, evolving reimbursement models &mdash; and position the platform to capture emerging opportunities before they become consensus.
 
 
 As the vertical matures, scope includes building and leading a dedicated medtech team across solutions, sales support, and customer delivery.
 
 
 
 Qualifications
 
 
 
 
 Required
 
 
 
 <ul>
 <li>
 7&ndash;15 years of experience in medical device commercial operations, patient engagement, clinical support, field operations, or related functions within device manufacturers, medtech services organizations, or healthcare services companies serving the device industry.
 </li>
 <li>
 Deep, hands-on operational knowledge of medical device workflows including surgical case support, post-surgical patient follow-up, device onboarding and training, field clinical operations, complaint handling, post-market surveillance, device registries, and HCP engagement programs.
 </li>
 <li>
 Direct experience building, managing, or designing device patient support programs, clinical education initiatives, or field operations &mdash; not just selling into them or advising from the outside.
 </li>
 <li>
 Demonstrated ability to engage credibly with senior medtech executives (VP, SVP, C-suite) across commercial, clinical, service, quality, and regulatory functions &mdash; and to drive deals to close, not just build relationships.
 </li>
 <li>
 Experience translating operational knowledge into solution design, product requirements, go-to-market strategy, or technology platform capabilities.
 </li>
 <li>
 Strong understanding of the medical device commercial model &mdash; capital equipment vs. consumables vs. implantables dynamics, surgeon preference and adoption cycles, hospital and ASC procurement, GPO contracting, and field sales and clinical specialist operating models.
 </li>
 <li>
 Comfort with commercial ownership &mdash; pipeline targets, revenue accountability, and the expectation that you are building a business line, not just advising on one.
 </li>
 <li>
 Comfort working in high-growth environments with limited structure and high expectations for ownership, cross-functional collaboration, and hands-on contribution across strategy, selling, and delivery.
 </li>
 <li>
 Exceptional communication skills &mdash; written, verbal, and visual &mdash; with the ability to make complex device operations accessible to technical, commercial, and executive audiences.
 
 
 </li>
 </ul>
 
 Preferred
 
 
 
 <ul>
 <li>
 Experience at a major medical device manufacturer or medtech services organization in an operational, commercial, strategy, or product capacity.
 </li>
 <li>
 Familiarity with device industry technology platforms including CRM systems, field service management tools, surgical scheduling systems, device telemetry platforms, and EHR integration standards.
 </li>
 <li>
 Understanding of FDA device regulations, 510(k) and PMA pathways, post-market surveillance requirements, MDR/IVDR, UDI, and quality system regulations as they relate to commercial operations and patient engagement.
 </li>
 <li>
 Experience leading or heavily influencing enterprise sales or go-to-market efforts as a subject matter expert, solutions lead, or commercial owner.
 </li>
 <li>
 Understanding of reimbursement dynamics including DRG, ASP, bundled payments, and value-based device contracting as they intersect with device adoption and patient support.
 </li>
 <li>
 Experience with AI, digital health, remote monitoring, or connected device technologies.
 </li>
 <li>
 Startup or early-stage company experience with direct revenue or P&amp;L-adjacent accountability.
 </li>
 <li>
 Advanced degree (MBA, MS, MSE, PhD) or clinical degree (MD, RN, PA) is a plus.
 
 
 </li>
 </ul>
 
 What We're Looking For
 
 
 
 A medical device authority who has operated inside the ecosystem &mdash; someone who has managed field teams, handled surgeon complaints at 6 AM, and felt the pressure of a new device launch. You are a solutions thinker who can articulate how AI transforms device operations with specificity, a commercial leader who can own a number and build a pipeline, and an internal force multiplier who makes everyone around you smarter about the device world. You don't wait for structure &mdash; you build it.
 
 
 
 Please be aware of recruitment scams impersonating Hippocratic AI. All recruiting communication will come from @
 
 
 hippocraticai.com
 
 
 email addresses. We will never request payment or sensitive personal information during the hiring process.
 
</div>

VP, MedTech & Devices

Intertek

<div></div><div>Medical Device Auditors - Full-time - Travel based Auditor.
Interested in future career opportunities in the Quality Assurance audit and support services industry? We're looking for a Medical Device Auditor that wants to build something great with an incredible group of people. By joining Intertek, your contributions will be valued as we continue to help the world Build Back Ever Better.
Intertek's Business Assurance team goes beyond testing, inspection and certification to look at the underlying elements that make a company and its products successful. Our assurance solutions provide confidence and total peace of mind that a client's operating procedures, systems and people are functioning properly to provide a competitive advantage in the marketplace.
What are we looking for?
The Auditor, Medical Devices will support the Business Assurance business by leading and/or participating as an assessor during all phases of a client&rsquo;s management system, in accordance with the company&rsquo;s accredited certification program. The Auditor is the primary interface with the client before and during the process of all auditing activities. Additionally, the Auditor will help train low-graded Auditors through witness audits, technical support, and education of both client and sales force as needed.
This will be a travel-based position, with extensive travel to client sites required. Candidate must be comfortable traveling 3 to 5 nights per week. This is a remote position; however, applicants must reside in and be able to legally work in the United States.
Salary &amp; Benefits Information
Individual compensation packages are based on a variety of factors unique to each candidate including skill set, experience, qualifications, and other job-related reasons.
In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more.
What you&rsquo;ll do:<ul><li>
Audit client management systems for compliance with established standards, client, and/or industry requirements, government regulations, and other relevant standards, specifically ISO 13485, regulatory requirements for the US, Canada, Japan, Australia, and/or Brazil, and/or GMP regulatory requirements related to the medical device, pharmaceutical and/or cosmetic industry.</li><li>
Assist clients with questions relevant to the audit and/or certification process.</li><li>
Act as Lead Auditor or team member.</li><li>
Travel will include overnight 3 to 5 days per week, to various worksites and client locations .</li><li>
Coordinate audit activity with team members.</li><li>
Liaison with client regarding audit activity.</li><li>
Review client's quality management system documentation</li><li>
Verify and document evidence of compliance and non-compliance.</li><li>
Prepare audit report.</li><li>
Review audit results with coordinator and other assessment team members. Make presentations to clients and/or certification board concerning audit results, when required.</li><li>
Assist with corrective action requirements resulting from assessments.</li><li>
Participate in audit meetings.</li><li>
Review audit reports and provide technical assistance to the medical team.</li><li>
Support management in areas of continuous improvement.</li><li>
Provide management with updates on status of work, initiatives, and projects, as required.</li></ul>
This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.
Minimum Requirements &amp; Qualifications:<ul><li>
4 year college/university degree in a science or technical field (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics) or equivalent combination of relevant education and work experience.</li><li>
A minimum of 4+ years of full-time work experience in a medical device or related medical device industry (design, development, testing, quality assurance/quality control).</li><li>
A minimum of 2+ years in a quality management systems environment (auditing, CAPA, complaints, management review)</li><li>
Completed Lead Auditor training for any standard (preferably ISO 13485 and/or relevant regulatory requirements), but will train if needed.</li><li>
Strong communication and interpersonal skills.</li><li>
Sound judgment, organizational, and analytical skills.</li><li>
Excellent computer and writing skills.</li><li>
Ability to define problems, collect data, establish facts, and draw valid conclusions.</li><li>
Ability to exercise effective time management skills in completion of assignments.</li><li>
Must be willing and able to travel extensively. Primarily domestic travel, some international travel may be needed (typically includes USA+Canada+Mexico).</li><li>
Possess a valid unrestricted driver&rsquo;s license and the ability to operate a motor vehicle in the performance of the official duties of the position.</li></ul>
Preferred Requirements &amp; Qualifications:<ul><li>
Lead Auditor Training with (ISO19011 OR ISO13485) Certification</li><li>
Related 3rd party auditing industry management systems experience.</li><li>
Working knowledge of relevant regulatory requirements for medical devices and pharmaceuticals in the EU, US, Australia, Japan, Brazil, and/or Canada.</li><li>
Experience implementing/auditing to ISO 13485, ISO 14971, and medical device regulatory requirements.</li><li>
Device Industry experience with Orthopedic implants, Active devices, Software as a medical device, Monitoring devices, IVF and ART devices, and sterility requirements (ETO, GAMMA).</li><li>
Specific experience/training on processes used in the relevant industry&rsquo;s manufacturing (ex. sterilization, machinery, electric and electronic devices or components, software development).</li><li>
Training/experience in quality tools (Kaizen, lean manufacturing, etc.).</li></ul> 
PHYSICAL REQUIREMENTS:
This role requires the ability to:<ul><li>
Ascend or descend ladders, stairs, ramps, and the like, using feet and legs and/or hands and arms. Body agility is emphasized.</li><li>
Stand, for sustained periods of time.</li><li>
Walk, moving on foot to accomplish tasks and to move from one work location to another.</li><li>
Communicate well, thru spoken word, conveying detailed accurate information &amp; instructions to others.</li><li>
Hear well, perceiving sounds with or without correction, including the ability to receive information thru oral communications.</li><li>
Exert up to 10 pounds of force occasionally and/or negligible amounts of force frequently to lift, carry, push, pull or otherwise move objects.</li><li>
Have close visual acuity to perform an activity such as preparing &amp; analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devises.</li></ul>
Intertek: Total Quality. Assured.
Intertek is a world leader in the Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. With passion, pace, and precision we work to exceed our customers&rsquo; expectations, while engaging with our employees to be 10X in their performance and professional growth.
Intertek is a drug-free workplace. As a condition of employment, certain positions may be required to pass a pre-employment drug test based on the type of work that will be performed.
We Value Diversity
Intertek&rsquo;s network of phenomenal people are our greatest assets, and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.
For individuals with disabilities who would like to request accommodation, or who need assistance applying, please email intertekhrusa@intertek.com or call 1-877-694-8543 (option #5) to speak with a member of the HR Department. 
#LI-Remote
#LI-JC1<ul><li>Intertek does not accept unsolicited approaches from agencies and will not pay a fee for any placement resulting from the receipt of an unsolicited resume.
</li></ul>The Business Assurance group of Intertek provides a full range of business process audit and support services, including management systems certification, sustainability and responsible sourcing audits, risk management, and training. Our range of bespoke auditing, performance benchmarking and supply chain solutions provide insight into every aspect of operations, allowing clients to make informed decisions about their business while ensuring their workforce competencies are current and relevant.Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.</div>

Auditor, Medical Devices - Full-Time

Blackrock Neurotech

<div>Job Title: Principal Systems Engineer
Company: Adraxe
Job Type: Full-Time
Location: Plymouth, MN (Hybrid)<h1 class="jobSectionHeader">
Adraxe - Company Overview</h1>
Adraxe Corporation is an innovative medical device startup focused on the design, development, and launch of breakthrough, minimally invasive neuromodulation solutions to address unmet patient needs. The results from the first clinical epilepsy patients are encouraging and we are at the important stage of hiring key personnel, to accelerate our progress and starting our full product and clinical development. Our goal is to revolutionize neurological care with life-compatible, closed-loop neuromodulation therapies, starting with epilepsy. 
About the role 
We are seeking a highly experienced and technically driven Principal Systems Engineer to lead systems engineering for a closed-loop epilepsy therapy system, with primary emphasis on neural interface performance, end-to-end system integration, full-stack data flow, and optimization of seizure detection algorithms within a regulated (PMA) development framework. The system includes an active implantable medical device (AIMD), custom external instruments, clinician and patient applications, and a secure cloud platform. 
The ideal candidate is a systems engineer who is strongest at the intersection of neural signals + real world data + integrated system behavior who can reason from electrode physics to algorithm metrics to telemetry and cloud pipelines, and knows how to turn that into testable requirements and credible verification evidence. The ideal candidate;<ul><li>
Has owned or heavily influenced signal chain and algorithm performance in embedded, constrained systems and is comfortable building evaluation frameworks and test plans that reflect reality, not ideal lab conditions.</li><li>
Understands that &ldquo;algorithm performance&rdquo; isn&rsquo;t just a model score&mdash;it&rsquo;s latency, robustness, power, reliability, data quality, and user workflow.</li><li>
Can lead cross-functional teams through integration complexity with discipline appropriate for PMA.</li></ul> 
This position will report directly to the VP of Engineering, will have significant input into Adraxe strategy and planning, and will collaborate closely with all technical disciplines at Adraxe. 
What you'll do 
Systems Architecture and Technical Leadership<ul><li>
Define and maintain the system architecture spanning implant, external instruments, clinician/patient applications, and cloud services.</li><li>
Lead trade studies (power, latency, telemetry, sensing/stimulation performance, reliability, safety, cybersecurity) and drive decisions with cross-functional alignment.</li><li>
Establish and manage interfaces (electrical, RF/telemetry, APIs, data models, workflow integrations) and ensure compatibility across subsystems.</li><li>
Guide development of closed-loop control concepts (sensing detection/classification therapy delivery adaptation), including system-level performance metrics and constraints.</li></ul>
Neural Interface &amp; Signal Chain Ownership<ul><li>
Develop deep system-level understanding of the neural interface (electrode-tissue interface, sensing modalities, impedance behavior, artifact sources, saturation, noise, drift) and how it impacts detection and therapy performance.</li><li>
Define and manage requirements for the signal chain (front-end analog, ADC, filtering, sampling, dynamic range, stimulation artifact handling, telemetry constraints) and ensure traceability to detection performance and safety.</li><li>
Partner with hardware, firmware, and clinical teams to characterize signal quality across populations and conditions (movement, sleep, medication changes, electrode maturation).</li></ul>
Seizure Detection Algorithm Performance &amp; Optimization<ul><li>
Translate clinical needs into measurable algorithm performance metrics (e.g., sensitivity, false alarm rate, latency to detection, time-in-warning, robustness to artifacts) and establish acceptance criteria.</li><li>
Drive system-level optimization across algorithm + firmware + data pipeline to meet performance targets under real device constraints (compute, memory, power, latency).</li><li>
Lead closed-loop performance analyses that connect sensing detection therapy behavior, including edge cases and failure modes.</li><li>
Coordinate creation of curated datasets, labeling strategies, ground-truth definitions, and evaluation protocols (including subgroup and scenario performance).</li></ul>
End-to-End Data Flow &amp; Observability (Implant External Apps Cloud)<ul><li>
Define and validate the complete system data flow: on-device data generation, event markers, compression/packetization, telemetry, external device handling, app storage/display, cloud ingestion, processing, and analytics.</li><li>
Ensure data integrity across the lifecycle: time synchronization, identity mapping, provenance, audit trails, retention, and traceability required for regulated evidence.</li><li>
Specify and validate observability features: logging, metrics, error reporting, trace IDs, and tools to support troubleshooting, clinical workflows, and post-market surveillance.</li></ul>
System Integration &amp; Test Leadership (PMA-Grade Evidence)<ul><li>
Own the integrated system test strategy with emphasis on realistic, high-value integration coverage (HIL/SIL, simulated physiology, induced artifacts, telemetry stress, app/cloud failure modes).</li><li>
Define system-level test methods and rigs to validate sensing and detection performance under representative conditions (including stimulation artifact conditions if applicable).</li><li>
Drive integration readiness criteria, defect triage workflows, and release gating for end-to-end functionality.</li><li>
Ensure traceability from user needs and hazards to verification evidence across the integrated system.</li></ul>
Safety, Risk, and Performance Boundaries for Closed-Loop Operation<ul><li>
Lead identification of hazards and risk controls related to detection performance, therapy timing, and data integrity (e.g., missed detection, false positives, telemetry dropouts, timebase drift, data corruption).</li><li>
Define safe bounds and fallback behaviors (therapy limits, safe modes, detection confidence gating, watchdogs) and verify they work across system states and failures.</li></ul>
Verification, Validation, and Test Strategy<ul><li>
Lead design verification testing (DVT) and verification planning to ensure compliance with medical device standards and safety requirements.</li><li>
Ensure designs meet relevant standards (e.g., IEC 60601, ISO 14708, ISO 14971, EMI/EMC compliance).</li><li>
Define end-to-end system verification and validation strategy across implant + external + applications + cloud, including integration and system testing.</li><li>
Develop test environments (benchtop rigs, simulators, HIL/SIL as appropriate, clinical workflow simulations)</li><li>
Data-driven verification of sensing/detection/therapy performance (as applicable)</li><li>
Drive design reviews, ensure readiness for formal V&amp;V, and support PMA documentation and inspection readiness.</li></ul>
Cross-Functional Leadership and Mentorship<ul><li>
Lead technical alignment across firmware, hardware, algorithms, app engineering, cloud, clinical, quality, regulatory, and manufacturing.</li><li>
Mentor systems engineers and establish best practices for systems engineering rigor, documentation quality, and integration readiness.</li><li>
Communicate clearly with stakeholders, translating complex technical tradeoffs into decision-ready options and documented outcomes.</li></ul>
Qualifications 
Minimum Qualifications are:<ul><li>
B.S. in Systems, Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related field.</li><li>
10+ years (or equivalent) experience in systems engineering for complex electromechanical and software-intensive products; medical device experience strongly preferred.</li><li>
Demonstrated experience developing implantable and/or active therapeutic devices (e.g., neuromodulation, cardiac rhythm management, or similar).</li><li>
Experience with implantable sensing modalities and neural signals (e.g., iEEG/ECoG/SEEG or related), including artifact sources and long-term recording challenges.</li></ul>
Strong command of:<ul><li>
Requirements development, decomposition, and traceability</li><li>
System architecture and interface definition (ICDs)</li><li>
System integration and V&amp;V planning and execution for distributed systems</li><li>
Risk management and safety engineering in regulated contexts</li><li>
Proven ability to lead through influence across multi-disciplinary teams and drive cross-functional execution.</li><li>
Strong written and verbal communication skills, including the ability to produce clear, inspection-ready technical documentation.</li></ul> 
Preferred Qualifications<ul><li>
M.S. or Ph.D. in Electrical Engineering, Biomedical Engineering, or related field.</li><li>
Experience supporting PMA development (design controls, DHF evidence, traceability, and system V&amp;V evidence packages).</li><li>
Experience with seizure detection/classification and/or robust biosignal detection methods in real-world settings.</li><li>
Experience designing and validating end-to-end data pipelines for regulated products (time sync, provenance, auditability, retention, access control).</li><li>
Strong background in system integration testing for distributed systems (embedded + apps + cloud), including SIL/HIL, simulation, and test automation.</li><li>
Working knowledge of cybersecurity engineering for connected medical systems (threat modeling, encryption, key management, vulnerability management).</li></ul> 
Physical and Other Requirements<ul><li>
This position is located in Plymouth MN.</li><li>
This position is a hybrid position with an expectation of roughly 75% in office and 25% remote work.</li><li>
This position requires approximately 15% Travel including international travel.</li></ul></div>

Adraxe: Principal Systems Engineer

Dynaflex Technologies

Compensation<ul><li>Base Salary: $54,000 annually (post-probation)</li><li>Ramp Period (First 3 Months): structured training with reduced base (~$40,800 annualized)</li><li>Additional Compensation: Commission, Performance Bonus, Benefits (medical, dental, vision, PTO</li></ul>This is a full-time, entry-level Sales Engineer role designed for individuals seeking a long-term career in med-tech. The first 3 months are a high-intensity probation period focused on performance, learning speed, and ownership. You will contribute to real customer work from day one. Evaluation based on technical learning speed, communication, work ethic, and ownership. Top performers transition into long-term rolesWhat We&rsquo;re Looking For<ul><li>Relentless follow-through</li><li>Technical curiosity</li><li>Commercial instinct</li><li>Coachability under pressure</li></ul>Basic Qualifications<ul><li>Bachelor&rsquo;s degree or equivalent experience</li><li>0&ndash;2 years experience (sales, engineering, or technical environment)</li></ul>Dynaflex is a medical device component manufacturer looking for responsible and hardworking individuals to join our growing team. We aim to make a difference in this world by making quality and innovative medical catheters/extrusion to improve patient outcomes. This is a family owned business and all our employees treat each other with care and respect. We believe that employees are part of a family instead of just numbers. Lots of opportunities to grow as we are a multinational operation with facilities in Northern California, Southern California, and Taiwan.We specialize in the areas including Neurovascular Coil Delivery, Heart Valve Repair and Replacement Catheter System, Steerable EP Catheters and Sheaths, Balloon and Self Expanding Stent Delivery Systems.We are looking for a motivated and well-spoken Sales Engineer to join our team. The Sales Engineer will be responsible for developing new leads, communicating with customers, understanding their needs, and ensuring a smooth sales process.To be successful as Sales Engineer, you should be able to build instant rapport and achieve customer satisfaction. Knowledge of medical devices, research and analytical skills, and the ability to explain clearly are highly desired skills.Sales Engineer Responsibilities:<ul><li>Serve customers by identifying their needs and engineering adaptations of products, equipment, and services.</li><li>Identify current and future customer service requirements by establishing personal rapport with potential and actual customers and others in a position to understand service requirements.</li><li>Provide product, service, or equipment technical and engineering information by answering questions and requests.</li><li>Establish new accounts by identifying potential customers and planning and organizing sales call schedules.</li><li>Prepare cost estimates by studying all related customer documents, consulting with engineers and other professional personnel.</li><li>Determine improvements by analyzing cost-benefit ratios of equipment, supplies, or service applications in customer environment and engineering or proposing changes in equipment, processes, or use of materials or services.</li><li>Gain customer acceptance by explaining or demonstrating cost reductions and operations improvements.</li><li>Prepares sales engineering reports by collecting, analyzing, and summarizing sales information and engineering and application trends.</li><li>Contribute to sales engineering effectiveness by identifying short-term and long-range issues that must be addressed, recommend options and courses of action, and implementing directives.</li><li>Contribute to team effort by accomplishing related results as needed.</li></ul>Sales Engineer Qualifications / Skills:<ul><li>Problem solving</li><li>Product knowledge</li><li>Selling to customer needs</li><li>Software requirements</li><li>Product development</li><li>Presentation skills</li><li>Technical understanding</li><li>Verbal communication</li><li>Requirements analysis</li><li>Innovation</li></ul>Sales Engineer Requirements:<ul><li>Bachelor&rsquo;s degree in Engineering preferred (Biomedical, Industrial, Mechanical, or Electrical), or equivalent industry experience</li><li>Previous experience in an outbound call center or a related sales position preferred.</li><li>Proficiency in Microsoft Office</li><li>Ability to read and understand documents</li><li>Ability to communicate needs and follow up</li><li>Attention to detail</li><li>Ability to work with sensitive material</li><li>Seeking someone who is driven, communicates well, has a good hardworking attitude.</li></ul>Job Type: Full-timePay: From $54,000.00 per yearBenefits:<ul><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li></ul>People with a criminal record are encouraged to applyWork Location: In person

Sales Engineer (Medical Devices)

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