medical device engineer

CommonSpirit Health

<div><b>Job Summary and Responsibilities</b><div><br>
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><br>
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><b><br>
Job Requirements</b><div><br>
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><br>
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><b>
Where You'll Work</b><div><br>
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><b><br>
Pay Range</b><br>
$49.78 - $74.05 /hour</div>

Clinical Engineering Medical Device Security Engineer II

<div><b>Job Summary and Responsibilities</b><div><br>
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><br>
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><br>
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><b><br>
Job Requirements</b><div><br>
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><br>
</div><b>Where You'll Work</b><div><br>
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><b><br>
Pay Range</b><br>
$45.26 - $67.32 /hour</div>

Clinical Engineering Medical Device Security Engineer

<div><b>Job Summary and Responsibilities</b><div><br>
As our Clinical Engineering Med Device Senior Network Engineer, you will lead regional Clinical Engineering network functions and responsibilities.<br>
<br>
Every day you will collaborate with the CE Medical Device Security Team on remediation solutions, guide other technicians on complex medical device projects, and manage vendor-related vulnerabilities. You'll also contribute to the design and support of the CE IT environment, provide specialized repair for medical equipment, and ensure end-to-end security measures are implemented and integrated using the latest technologies.<br>
<br>
To be successful in this role, you will be jointly responsible for enhancing the security of our medical devices, networks, and information, and for resolving complex technical and business issues related to medical device security.</div><ul><li>
All associated Job responsibilities of the Clinical Engineering Medical Device Network Engineer I and II.</li><li>
Responsible for achieving and maintaining compliance of Clinical Engineering&rsquo;s cybersecurity and vulnerability program Key Performance Indicators within the assigned region.</li><li>
Responsible for communication and coordination with market senior leadership regarding security or IT related projects associated with medical devices within the assigned region.</li><li>
Lead cybersecurity and remediation and IT related projects associated with medical devices within the assigned region.</li><li>
Mentor and train CE staff in the delivery of device remediation and vulnerability patching and documentation.</li><li>
Lead and coordinate efforts for medical device patching and updating of firmware and/or applications appropriate for the medical device.</li></ul><br>
<b>
Job Requirements</b><div><br>
Required</div><ul><li>
Bachelors Other HTM, Computer Science, Technology, Business discipline or equivalent professional experience, upon hire</li><li>
Minimum of 7 Years in Clinical Engineering Networking Role or equivalent experience</li><li>
Experience with HIPPA/ HITECH compliance Standards</li><li>
Valid Driver's License</li></ul><div><br>
Preferred</div><ul><li>
Experience working with the software development life cycle or projectmanagement methodologies. Customer Service, Project Management,Strong Communication and Executive Level Presentation skills and relatedexperience.</li><li>
Certified Radiology Equipment Specialists, upon hire or</li><li>
CompTIA A+ Certification, upon hire or</li><li>
CompTIA Network +, upon hire</li></ul><div></div><b><br>
Where You'll Work</b><div><br>
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><b><br>
Pay Range</b><br>
$48.60 - $72.29 /hour</div>

Sr Clinical Engineering Medical Device Network Engineer

<div><b>Job Summary and Responsibilities</b><div><br>
As our Clinical Engineering Med Device Senior Network Engineer, you will lead regional Clinical Engineering network functions and responsibilities.<br>
<br>
Every day you will collaborate with the CE Medical Device Security Team on remediation solutions, guide other technicians on complex medical device projects, and manage vendor-related vulnerabilities. You'll also contribute to the design and support of the CE IT environment, provide specialized repair for medical equipment, and ensure end-to-end security measures are implemented and integrated using the latest technologies.<br>
<br>
To be successful in this role, you will be jointly responsible for enhancing the security of our medical devices, networks, and information, and for resolving complex technical and business issues related to medical device security.</div><ul><li>
All associated Job responsibilities of the Clinical Engineering Medical Device Network Engineer I and II.</li><li>
Responsible for achieving and maintaining compliance of Clinical Engineering&rsquo;s cybersecurity and vulnerability program Key Performance Indicators within the assigned region.</li><li>
Responsible for communication and coordination with market senior leadership regarding security or IT related projects associated with medical devices within the assigned region.</li><li>
Lead cybersecurity and remediation and IT related projects associated with medical devices within the assigned region.</li><li>
Mentor and train CE staff in the delivery of device remediation and vulnerability patching and documentation.</li><li>
Lead and coordinate efforts for medical device patching and updating of firmware and/or applications appropriate for the medical device.</li></ul><br>
<b>
Job Requirements</b><div><br>
Required</div><ul><li>
Bachelors Other HTM, Computer Science, Technology, Business discipline or equivalent professional experience, upon hire</li><li>
Minimum of 7 Years in Clinical Engineering Networking Role or equivalent experience</li><li>
Experience with HIPPA/ HITECH compliance Standards</li><li>
Valid Driver's License</li></ul><div><br>
Preferred</div><ul><li>
Experience working with the software development life cycle or projectmanagement methodologies. Customer Service, Project Management,Strong Communication and Executive Level Presentation skills and relatedexperience.</li><li>
Certified Radiology Equipment Specialists, upon hire or</li><li>
CompTIA A+ Certification, upon hire or</li><li>
CompTIA Network +, upon hire</li></ul><div></div><b><br>
Where You'll Work</b><div><br>
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><b><br>
Pay Range</b><br>
$53.46 - $79.52 /hour</div>

<div><b>Job Summary and Responsibilities</b><div><br>
As our Clinical Engineering Med Device Senior Network Engineer, you will lead regional Clinical Engineering network functions and responsibilities.<br>
<br>
Every day you will collaborate with the CE Medical Device Security Team on remediation solutions, guide other technicians on complex medical device projects, and manage vendor-related vulnerabilities. You'll also contribute to the design and support of the CE IT environment, provide specialized repair for medical equipment, and ensure end-to-end security measures are implemented and integrated using the latest technologies.<br>
<br>
To be successful in this role, you will be jointly responsible for enhancing the security of our medical devices, networks, and information, and for resolving complex technical and business issues related to medical device security.</div><ul><li>
All associated Job responsibilities of the Clinical Engineering Medical Device Network Engineer I and II.</li><li>
Responsible for achieving and maintaining compliance of Clinical Engineering&rsquo;s cybersecurity and vulnerability program Key Performance Indicators within the assigned region.</li><li>
Responsible for communication and coordination with market senior leadership regarding security or IT related projects associated with medical devices within the assigned region.</li><li>
Lead cybersecurity and remediation and IT related projects associated with medical devices within the assigned region.</li><li>
Mentor and train CE staff in the delivery of device remediation and vulnerability patching and documentation.</li><li>
Lead and coordinate efforts for medical device patching and updating of firmware and/or applications appropriate for the medical device.</li></ul><br>
<b>
Job Requirements</b><div><br>
Required</div><ul><li>
Bachelors Other HTM, Computer Science, Technology, Business discipline or equivalent professional experience, upon hire</li><li>
Minimum of 7 Years in Clinical Engineering Networking Role or equivalent experience</li><li>
Experience with HIPPA/ HITECH compliance Standards</li><li>
Valid Driver's License</li></ul><div><br>
Preferred</div><ul><li>
Experience working with the software development life cycle or projectmanagement methodologies. Customer Service, Project Management,Strong Communication and Executive Level Presentation skills and relatedexperience.</li><li>
Certified Radiology Equipment Specialists, upon hire or</li><li>
CompTIA A+ Certification, upon hire or</li><li>
CompTIA Network +, upon hire</li></ul><div></div><b><br>
Where You'll Work</b><div><br>
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><b><br>
Pay Range</b><br>
$46.17 - $68.67 /hour</div>

Precision Medical

<p>At Precision Medical, Inc., we are driven by a clear and unwavering mission: <b>to make people's lives better</b>. We achieve this by our deep commitment to create life-enhancing respiratory solutions through products and services that you can depend on. As a global leader in medical device manufacturing, we specialize in the design and production of precision-engineered respiratory equipment. From cutting-edge oxygen, air, and suction systems for healthcare facilities to at-home solutions like air compressors and aspirators, we develop products that empower both healthcare providers and patients.</p><p>We are a family-owned and operated company with a legacy of quality, innovation, and care that spans more than four decades. We measure success not only by our business growth but by the meaningful impact we have on the lives we touch&mdash;whether through improving patient care, supporting medical professionals, or fostering healthier communities.</p><p>Precision Medical is seeking a <b>Quality Assurance Engineer, Medical Device</b> to work on site at our facility in Northampton, PA.</p><p><b>Job Summary:</b></p><p>The Quality Assurance Engineer, Medical Device will act as a liaison between Quality and Engineering to ensure products meet or exceed safety, efficacy and reliability standards.</p><p><b>Duties/Responsibilities:</b></p><p>&middot; Create/update Risk Management files in compliance with ISO 14971:2019.</p><p>&middot; Create and maintain Medical Device files/Technical files.</p><p>&middot; Review literature and labels.</p><p>&middot; Create/revise Quality documentation.</p><p>&middot; Develop/control Quality Assurance databases.</p><p>&middot; Investigate complaints and coordinate recalls as assigned.</p><p>&middot; Maintain Material Safety Data Sheets.</p><p>&middot; Conduct analysis of data reports.</p><p>&middot; Perform any additional requested task necessary to ensure the successful operation of the company.</p><p><b>Required Skills/Abilities: </b></p><p>&middot; Excellent verbal and written communication skills.</p><p>&middot; Strong organizational skills and attention to detail.</p><p>&middot; Excellent time management skills with a proven ability to meet deadlines.</p><p>&middot; Proficient with Microsoft Office Suite.</p><p><b>Education and Experience:</b></p><p>Bachelor&rsquo;s degree in a science/engineering/health or other related field, or 3-5 years of experience in medical device industry.</p><p>Previous experience with ISO 13485:2016 required.</p><p><b>Physical Requirements: </b></p><p>Prolonged periods of sitting at a desk and working on a computer; ability to alternate between sitting, standing and walking as needed.</p><p><b>Precision Medical, Inc. is an equal opportunity employer.</b></p><p>Precision Medical, Inc. does not accept unsolicited resumes from search firms for this employment opportunity.</p><p>Pay: $65,000.00 - $71,000.00 per year</p><p>Benefits:</p><ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul><p>Work Location: In person</p>

Quality Assurance Engineer, Medical Device

Aptyx

<div><p>The R&amp;D Engineer II performs design engineering functions in support of medical device product development programs across multiple therapeutic areas including cardiology, neurology, and urology. This role contributes to projects from concept through commercialization, ensuring deliverables meet customer requirements for quality, cost, and schedule performance.</p><p>
The Engineer II works with moderate independence to execute engineering tasks, support project deliverables assigned by the Project Manager, and communicate technical status updates to cross-functional teams. Updates may include technical feasibility, schedule impact, budget considerations, and risk to project objectives.</p><p>
This role also supports development of engineering processes, manufacturing readiness, and continuous improvement of product and design solutions within a regulated environment.</p><p>
</p><p><b>Key Responsibilities</b></p><p><b>
Product DesignDevelopment</b></p><ul><li>
Follow the Aptyx Quality System, including all applicable SOPs and training requirements
</li><li>Develop and engineer medical devices from concept through production with little supervision
</li><li>Perform hands-on product assembly and process development for catheters and other medical devices
</li><li>Design devices, components, tooling, and fixtures using SolidWorks or equivalent CAD software
</li><li>Build prototypes and support laboratory-based development activities
</li><li>Engage with senior and principal engineers for technical guidance as needed
</li></ul><p></p><p><b>ManufacturingProcess Development</b></p><ul><li>
Design and develop pilot and production tooling, fixtures, equipment, and manufacturing procedures with limited supervision
</li><li>Support installation, setup, and qualification of new equipment, including development of preventive maintenance (PM) procedures as needed
</li><li>Perform or support equipment maintenance and coordinate re-entry to production use, escalating issues to the Technology Manager when appropriate
</li><li>Assess process feasibility and support manufacturing with validation planning and time studies
</li><li>Develop manufacturing methods and support product transition into full production
</li></ul><p></p><p><b>Validation, TestingDocumentation</b></p><ul><li>
Develop and execute verification and validation activities with limited supervision, including testing and documentation
</li><li>Prepare engineering documentation to support the quality system, including:
<ul><li>Test results and data analysis
</li><li>Engineering drawings
</li><li>Test reports
</li></ul></li><li>Ensure compliance with good documentation practices and regulatory requirements
</li><li>Support engineering changes and updates to existing product lines as needed
</li></ul><p></p><p><b>Project SupportCommunication</b></p><ul><li>
Communicate directly with project teams and leadership regarding task status, risks, and technical challenges
</li><li>Support execution of project deliverables assigned by the Project Manager
</li><li>Provide input on technical feasibility, schedule, and budget impacts
</li><li>Demonstrate understanding of the design and development (D&amp;D) process through execution of assigned work
</li><li>Support manufacturing and product development activities through commercialization
</li></ul><p></p><p><b>VendorCross-Functional Collaboration</b></p><ul><li>
Collaborate with external vendors on sourcing of materials, components, tooling, and manufacturing processes
</li><li>Support engineering teams in investigations related to customer complaints and product issues
</li><li>Work cross-functionally with Quality, Manufacturing, Supply Chain, and Project Management teams
</li></ul><p></p><p><b>Education</b></p><ul><li>
Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related discipline required
</li></ul><p></p><p><b>Experience</b></p><ul><li>
3+ years of engineering experience in medical device development or regulated manufacturing environment
</li><li>Experience with catheter-based or complex medical device development strongly preferred
</li></ul><p></p><p><b>SkillsQualifications</b></p><ul><li>
Proficiency in SolidWorks or equivalent CAD software
</li><li>Strong experience in hands-on prototyping and mechanical assembly
</li><li>Knowledge of medical device materials and manufacturing processes (e.g., thermal bonding, PTFE processing, fixture design, etc.)
</li><li>Familiarity with validation (IQ/OQ/PQ), design controls, and regulated product development processes
</li><li>Strong analytical and problem-solving skills
</li><li>Excellent verbal and written communication skills
</li><li>Proficiency in Microsoft Office Suite
</li><li>Ability to use basic hand tools (drills, screwdrivers, wrenches, saws, etc.)
</li><li>Familiarity with multiple manufacturing methods used in device production
</li></ul><p></p><p><b>Physical Requirements</b></p><ul><li>
Ability to work in both laboratory and manufacturing environments with variable conditions
</li><li>Frequent use of hands, arms, and fingers for engineering and technical tasks
</li><li>Ability to sit, stand, and move throughout production and lab environments
</li><li>Normal vision and hearing required for communication and technical work
</li><li>Must be able to effectively communicate in person, electronically, and via phone
</li></ul><p></p><p><b>Performance Expectations</b></p><ul><li>
Adherence to the Aptyx Quality System and SOP compliance requirements
</li><li>Timely and accurate completion of engineering deliverables and documentation
</li><li>Clear and proactive communication of task status, risks, and technical issues
</li><li>Consistent on-time and on-budget execution of assigned work
</li><li>Proficiency in SolidWorks and adherence to internal drawing/documentation standards
</li><li>Demonstrated understanding of multiple medical device manufacturing technologies (e.g., bonding, fixture design, PTFE processing, etc.)
</li><li>Strong understanding of the design and development (D&amp;D) process and its impact on project execution
</li><li>Demonstrated growth in technical capability, independence, and problem-solving ability</li></ul></div><p></p>

R&D Engineer Associate Level - Level II

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R&D Engineer Associate Level - Level II