medical device engineer

Tech Pinacle Innovation Pvt Ltd

<p><b>Job Title:</b> Medical Device Integration Engineer</p><p><b>Role Summary</b></p><p>The Medical Device Integration Engineer is responsible for designing, implementing, and supporting integration between bedside medical devices and Electronic Health Record (EHR) systems. This role ensures accurate, secure, and real-time clinical data exchange to support patient safety and operational efficiency. The ideal candidate will possess strong healthcare integration expertise, knowledge of medical device communication standards, and hands-on experience supporting real-time clinical workflows.</p><p><b>Key Responsibilities</b></p><p><b>Medical Device Integration &amp; Support</b></p><ul><li>Design, configure, and support integration between bedside medical devices and EHR systems.</li><li>Work with devices such as vital signs monitors, ventilators, infusion pumps, anesthesia machines, ECG/telemetry systems, and smart beds.</li><li>Ensure reliable real-time device-to-EHR data exchange.</li><li>Support device onboarding, configuration, and validation in clinical environments.</li><li>Troubleshoot device connectivity, mapping, and data flow issues.</li></ul><p><b>Healthcare Interoperability &amp; Messaging</b></p><ul><li>Configure and support HL7 messaging (ADT, ORU, ORM).</li><li>Perform flowsheet mappings and clinical data validation.</li><li>Support FHIR/REST API&ndash;based device integrations.</li><li>Ensure compliance with interoperability standards and healthcare data regulations.</li></ul><p><b>Device Connectivity &amp; Infrastructure</b></p><ul><li>Support serial-to-IP device connectivity and converters.</li><li>Apply knowledge of IEEE 11073 medical device communication standards.</li><li>Monitor devices using SNMP, syslog, and device monitoring tools.</li><li>Coordinate with network and infrastructure teams to ensure secure connectivity.</li></ul><p><b>Programming &amp; Automation</b></p><ul><li>Develop scripts or tools using Java, C++, .NET, Python, or JavaScript to support integration workflows.</li><li>Automate monitoring, alerting, and troubleshooting processes.</li><li>Contribute to system performance optimization and scalability improvements.</li></ul><p><b>AI &amp; Advanced Technologies (Preferred)</b></p><ul><li>Utilize and build AI-driven tools (LLMs, Agentic AI) to enhance monitoring, troubleshooting, or automation.</li><li>Explore AI-assisted clinical data validation and integration diagnostics.</li><li>Support intelligent automation initiatives within clinical engineering environments.</li></ul><p><b>Collaboration &amp; Documentation</b></p><ul><li>Partner with clinical engineering, IT, EHR teams, and biomedical staff.</li><li>Document interface specifications, mapping documents, and troubleshooting guides.</li><li>Participate in system upgrades, device rollouts, and go-live support.</li><li>Conduct root cause analysis and support incident resolution.</li></ul><p><b>Required Qualifications</b></p><ul><li>5+ years of hands-on experience with medical device integration in a healthcare setting.</li><li>Strong understanding of bedside clinical devices and workflows.</li><li>Proficiency in HL7 messaging (ADT, ORU, ORM).</li><li>Experience supporting real-time device-to-EHR data exchange.</li><li>Knowledge of serial-to-IP connectivity and device converters.</li><li>Familiarity with IEEE 11073 standards.</li><li>Knowledge of SNMP, syslog, and monitoring technologies.</li><li>Experience with at least one programming or scripting language.</li></ul><p><b>Preferred Qualifications</b></p><ul><li>Experience with FHIR and REST API&ndash;based integrations.</li><li>Experience with AI tools (LLMs, Agentic AI).</li><li>Experience working in large hospital or multi-site healthcare environments.</li><li>Understanding of cybersecurity principles in medical device integration.</li></ul><p><b>Key Competencies</b></p><ul><li>Healthcare interoperability</li><li>HL7 &amp; FHIR integration</li><li>Medical device communication standards</li><li>Real-time clinical workflow support</li><li>Integration troubleshooting</li><li>Automation &amp; scripting</li><li>Cross-functional collaboration</li></ul><p>Job Types: Full-time, Permanent</p><p>Pay: ₹394,835.26 - ₹868,919.69 per year</p><p>Work Location: Hybrid remote in Noida</p>

Medical Device Integration Engineer

Biosorin Pvt Ltd

<p>A <b>Medical Device Firm</b> is looking for a <b>Biomedical Service Engineer</b> for it's Biomedical Support and Engineering Department.</p><p><b>Requirements</b>:</p><p>Bio-Medical Engineering or Equivalent with 0-1 year of relevant experience.</p><p>Fresh Graduates are encouraged to apply.</p><p>Job Types: Full-time, Contract</p><p>Work Location: In person</p>

Biomedical Service Engineer

Enhanced Compliance Inc.

<div><p><b>About ECI</b><br>
ECI&rsquo;s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment &amp; benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.</p><br>
<p></p>
<p><b>
About the Role</b><br>
As Senior R&amp;D Engineer you will support DHF remediation activities for our client.</p>
<div>
<ul><li>Support design history file remediation activities associated with the client&rsquo;s division, including as needed but not limited to: Design Inputs, Design Outputs, Design Verification, Design Validation and Risk Management.</li></ul>
</div><div><ul><li>Interface with client&rsquo;s team members along with coordinating activities within our client&rsquo;s Quality Management System
</li></ul></div><div><ul><li>Additional items discussed between client and ECI as determined reasonably will not require scope re-evaluation. Product lines associated with the division and design history file documentation creation, updates, and approval within the client&rsquo;s documentation management system.</li></ul>
</div><div><ul><li>Develops new products and or sustains current products including single use devices, and capital equipment devices with software and hardware (medical device systems) with minimal supervision to develop, maintain or improve current released device design and/or quality. Support team to develop and executes plans for a design and development/design change projects following design control requirements</li></ul>
</div>
<p><b>What We Look For</b></p>
<ul><li>
Bachelor&rsquo;s degree in engineering or equivalent work experience</li><li>
Minimum of 5 (Five) years direct R&amp;D experience in medical device industry working with electromechanical devices</li><li>
Experience with durable medical capital equipment in addition to single-use-devices is preferred</li><li>
Excellent written and verbal communication skills with good presentation and technical writing skills</li><li>
Collaborative attitude with the ability to work well in a team environment</li><li>
Strong engineering, design, and analysis skills along with experience with medical devices from concept to commercialization</li><li>
Understanding of FDA Quality Systems Regulations</li></ul><br>
<p></p>
<p><b>
ECI is an equal opportunity employer.</b></p>
<p><b>
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.</b></p>
<p><b>
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.</b></p></div><p></p>

Senior R&D Engineer - Medical Device #1140

<p></p><div><p><b>About ECI</b><br>
ECI&rsquo;s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment &amp; benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.</p><br>
<p></p>
<p><b>
About the Role</b><br>
As Senior R&amp;D Engineer you will support DHF remediation activities for our client.</p>
<div>
<ul><li>Support design history file remediation activities associated with the client&rsquo;s division, including as needed but not limited to: Design Inputs, Design Outputs, Design Verification, Design Validation and Risk Management.</li></ul>
</div><div><ul><li>Interface with client&rsquo;s team members along with coordinating activities within our client&rsquo;s Quality Management System
</li></ul></div><div><ul><li>Additional items discussed between client and ECI as determined reasonably will not require scope re-evaluation. Product lines associated with the division and design history file documentation creation, updates, and approval within the client&rsquo;s documentation management system.</li></ul>
</div><div><ul><li>Develops new products and or sustains current products including single use devices, and capital equipment devices with software and hardware (medical device systems) with minimal supervision to develop, maintain or improve current released device design and/or quality. Support team to develop and executes plans for a design and development/design change projects following design control requirements</li></ul>
</div>
<p><b>What We Look For</b></p>
<ul><li>
Bachelor&rsquo;s degree in engineering or equivalent work experience</li><li>
Minimum of 5 (Five) years direct R&amp;D experience in medical device industry working with electromechanical devices</li><li>
Experience with durable medical capital equipment in addition to single-use-devices is preferred</li><li>
Excellent written and verbal communication skills with good presentation and technical writing skills</li><li>
Collaborative attitude with the ability to work well in a team environment</li><li>
Strong engineering, design, and analysis skills along with experience with medical devices from concept to commercialization</li><li>
Understanding of FDA Quality Systems Regulations</li></ul><br>
<p></p>
<p><b>
ECI is an equal opportunity employer.</b></p>
<p><b>
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.</b></p>
<p><b>
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.</b></p></div><p></p>

Senior R&D Engineer - Medical Device #1139

ProKatchers LLC

<div>
 <p>
  <strong>
   Job Title :
  </strong>
  Mechanical Engineer IV
 </p>
 <p>
  <strong>
   Location :
  </strong>
  Burlington, MA 01803
 </p>
 <p>
  <strong>
   Duration :
  </strong>
  12 months
 </p>
 <p>
  <strong>
   What You&rsquo;ll Work On
  </strong>
 </p>
 <ul>
  <li>
   Specify, design, verify, and validate mechanical components and subsystems for LVADs in accordance with regulatory and quality standards.
  </li>
  <li>
   Apply empirical, numerical, and experimental analysis (FEA, CFD, etc.) to evaluate and optimize designs for performance, reliability, and manufacturability.
  </li>
  <li>
   Develop and execute test methods and simulation models to mitigate design risks and ensure product robustness.
  </li>
  <li>
   Lead design reviews, risk assessments, and documentation efforts including CAD models, specifications, and technical reports.
  </li>
  <li>
   Collaborate with cross-functional teams including systems, electrical, software, clinical, and manufacturing engineering.
  </li>
  <li>
   Interface with suppliers and internal teams to source prototype and production components.
  </li>
  <li>
   Mentor junior engineers and contribute to a culture of technical excellence and continuous improvement.
  </li>
 </ul>
 <p>
  <strong>
   Required Qualifications
  </strong>
 </p>
 <ul>
  <li>
   Bachelor&rsquo;s degree in Mechanical Engineering or related STEM field.
  </li>
  <li>
   6+ years of experience in mechanical design and development, preferably in the medical device industry.
  </li>
  <li>
   Proficiency in SolidWorks or equivalent CAD software and FEA tools (e.g., COMSOL).
  </li>
  <li>
   Strong understanding of materials, manufacturing processes, and design for reliability.
  </li>
  <li>
   Demonstrated ability to lead technical projects and deliver results in a regulated environment.
  </li>
  <li>
   Excellent communication and documentation skills.
  </li>
 </ul>
</div>


Mechanical Engineer

Capgemini

<div><div><div><p>Pune</p><div>
Design Engineer - Medical Devices</div><p>
</p></div></div><div></div><div><div><div><div><div><p>
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world&rsquo;s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&amp;D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.</p><div><div><div><div>
Job Description</div></div><div><p>
JD- Mechanical Design Engineer ( Medical Devices )<br>
Experience: Minimum 6 years<br>
Education: B.E / M.E in Mechanical Engineering / Machine Design<br>
<br>
Required Skills &amp; Competencies<br>
Strong hands-on experience in Creo, Windchill, and engineering standards.<br>
Proficiency in sheet metal, plastic, and structural part design.<br>
Good understanding of manufacturing processes, GD&amp;T, tolerancing, and design for manufacturability/assembly (DFM/DFA).<br>
DFMEA, Reliability, Design verification<br>
Solid grasp of design calculations (structural, mechanism, tolerance stack-up).<br>
Knowledge of medical device regulatory standards (ISO 13485, IEC 60601 1).<br>
Strong problem-solving mindset with the ability to drive solutions independently.<br>
Team player with excellent communication, continuous learning attitude, and ability to work in a fast paced environment.<br>
Demonstrates ownership, decision-making ability, and commitment to high quality deliverables.<br>
<br>
Behavioral Attributes<br>
Self-driven, proactive, and committed to continuous learning.<br>
Hard working, disciplined, and strong in execution.<br>
Team-oriented with excellent collaboration skills.<br>
Shows ownership, accountability, and effective decision-making.</p></div></div><div><div><div>
Job Description - Grade Specific</div></div><div>
Focus on Mechanical and Physical Engineering. Develops competency in own area of expertise. Shares expertise and provides guidance and support to others. Interprets clients needs. Completes own role independently or with minimum supervision. Identifies problems and relevant issues in straight forward situations and generates solutions. Contributes in teamwork and interacts with customers.</div></div></div><p>
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.</p></div></div><div><div><div>
<div><div>Ref. code</div><div>
420403-en_GB</div></div><div><div>
Posted on</div><div>
20 Feb 2026</div></div><div><div>
Experience level</div><div>
Experienced Professionals</div></div><div><div>
Contract type</div><div>
Permanent</div></div><div><div>
Location</div><div>
Pune</div></div><div><div>
Business unit</div><div>
Engineering and RandD Services</div></div><div><div>
Brand</div><div>
Capgemini Engineering</div></div><div><div>
Professional communities</div><div>
Products &amp; Systems Engineering</div></div></div></div></div></div></div></div></div><p></p>

Design Engineer - Medical Devices

Tata Elxsi

<div>
 <p>
  Tata Elxsi is truly your home to a billion possibilities. We believe in opportunities for everyone to be bold and curious and seek to shape the future. Explore what&rsquo;s possible, discover what you love to do, and find accelerated paths for growth. At Tata Elxsi, you matter.
 </p>
 <p>
  <br/>
 </p>
 <p>
  Role- Labelling Specialist
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Description:
  </strong>
 </p>
 <p>
  The Label Designer for re-designing medical device labels as per brand standard guidelines for regulatory compliance. Label designer should be well-versed in Loftware Spectrum&reg; 4.6 version or 4.2 version. Provide creative solutions in medical device labelling and packaging design and validation.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Title:
  </strong>
  Label Specialist / SME
 </p>
 <p>
  <strong>
   Experience:
  </strong>
  5 - 15 years
 </p>
 <p>
  <strong>
   Domain:
  </strong>
  Medical Device
 </p>
 <p>
  <strong>
   Location:
  </strong>
  Pune
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Key Responsibilities:
  </strong>
 </p>
 <p>
  &bull; Develop and manage product labeling to ensure compliance with FDA, EU MDR, Health Canada, Global countries, UDI, and standards such as ISO 20417 and ISO 15223.
 </p>
 <p>
  &bull; Collaborate with cross-functional teams to develop label content and support the creation of Instructions for Use (IFU) and Operations Manuals.
 </p>
 <p>
  &bull; Create labelling input and specification documents.
 </p>
 <p>
  &bull; Lead and participate in design review meetings for label artwork, specifications, IFUs, and marketing collaterals.
 </p>
 <p>
  &bull; Develop and update labeling specifications, artwork files, and supporting documentation; coordinate translation requests.
 </p>
 <p>
  &bull; Review First Article Inspection (FAI) reports, verify final content, and support barcode grading and qualification.
 </p>
 <p>
  &bull; Provide support to resolve technical and operational labeling issues.
 </p>
 <p>
  &bull; Conduct design reviews for updated documents and complete Document Change Request (DCR) reviews in a timely and objective manner.
 </p>
 <p>
  &bull; Create and route Labeling Change order in PLM and ensure effective change management coordination using PLM tools such as Windchill and Agile.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Required Skills &amp; Experience:
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  &bull; Proven experience in medical device labeling and regulatory documentation.
 </p>
 <p>
  &bull; Proficiency in Loftware Cloud and Loftware Spectrum (hands-on or working knowledge).
 </p>
 <p>
  &bull; Strong command of Adobe Creative Suite (Illustrator, Photoshop, etc.).
 </p>
 <p>
  &bull; Hands-on or working knowledge of Windchill PLM and Agile PLM systems.
 </p>
 <p>
  &bull; In-depth understanding of global labeling requirements, including US, Canada, EU MDR, Australia, LATAM, and EMEA regions.
 </p>
 <p>
  &bull; Familiarity with regulatory standards such as IEC 60601, ISO 20417, and ISO 15223.
 </p>
 <p>
  &bull; Experience working in multidisciplinary teams.
 </p>
 <p>
  &bull; Excellent interpersonal, written, and oral communication skills.
 </p>
 <p>
  &bull; Strong organizational and project coordination abilities.
 </p>
 <p>
  &bull; High attention to detail and commitment to quality.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Educational Qualification:
  </strong>
 </p>
 <p>
  &bull; Degree preferred, MTech / BE/ BTECH( Mechanical/Bio-medical/ Eq
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Good to have:
  </strong>
 </p>
 <ul>
  <li>
   Experience in Adobe Illustrator, Adobe In-design, Adobe Photoshop, MS Office
  </li>
 </ul>
 <p>
 </p>
</div>


Labelling SME (Medical devices)

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