Senior/Staff R&D Engineer - Reliability

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    "description_html": "<p>&nbsp;&nbsp;</p><p><strong>Test Strategy and Planning</strong></p><ul><li>Develop and lead the Design Verification and Validation (V&amp;V) plan in compliance with regulatory and quality system requirements (21 CFR Part 820, ISO 13485, ISO 14971).</li><li>Define test strategies, protocols, and acceptance criteria for mechanical, electrical, optical, and system-level performance.</li><li>Ensure traceability of test activities to design inputs, risk controls, and user needs in collaboration with Systems and Quality teams.</li><li>Create and maintain test master plans, schedules, and resource allocation for multiple device programs.</li></ul><p><strong>Test Execution and Oversight</strong></p><ul><li>Lead the development, validation, and maintenance of test fixtures, setups, and custom test equipment.</li><li>Supervise and mentor test engineers and technicians during bench testing, environmental testing, and reliability studies.</li><li>Ensure accurate and timely execution of design verification and validation activities, including integration, performance, and system testing.</li><li>Oversee test data analysis, reporting, and documentation per good documentation practices (GDP).</li><li>Support root cause analysis and corrective actions for non-conformances or test failures.</li></ul><p><strong>Compliance and Documentation</strong></p><ul><li>Ensure all test documentation complies with FDA 21 CFR 820.30 (Design Controls), ISO 13485, and other applicable standards (e.g., IEC 60601, IEC 62304, ISO 14971, IEC 61010, ASTM, etc.).</li><li>Lead test method validation (TMV) and calibration documentation to ensure test integrity.</li><li>Support internal and external audits, design reviews, and regulatory submissions (510(k), CE marking).</li></ul><p><strong>Cross-Functional Collaboration</strong></p><ul><li>Partner with Design, Systems, Quality, Regulatory, and Manufacturing Engineering teams to ensure smooth transition from development to production.</li><li>Provide technical input for risk management, usability engineering, and design for manufacturability (DFM) activities.</li><li>Contribute to supplier and component qualification testing as needed.</li></ul><p><strong>Test Lab Oversight</strong></p><ul><li>Leads lab readiness and organization with support of R&amp;D technicians and engineers – including, equipment calibration, maintenance, and supplies</li><li>Identifies, proposes, plans, and implements continuous improvements to enhance test lab capabilities for driving clinically relevant evaluations and real-world reliability improvements</li></ul>",
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      "datePosted": "2026-06-04T17:39:48-05:00",
      "description": "<p>Description</p><p>  </p><p><strong>Test Strategy and Planning</strong></p><ul><li>Develop and lead the Design Verification and Validation (V&V) plan in compliance with regulatory and quality system requirements (21 CFR Part 820, ISO 13485, ISO 14971).</li><li>Define test strategies, protocols, and acceptance criteria for mechanical, electrical, optical, and system-level performance.</li><li>Ensure traceability of test activities to design inputs, risk controls, and user needs in collaboration with Systems and Quality teams.</li><li>Create and maintain test master plans, schedules, and resource allocation for multiple device programs.</li></ul><p><strong>Test Execution and Oversight</strong></p><ul><li>Lead the development, validation, and maintenance of test fixtures, setups, and custom test equipment.</li><li>Supervise and mentor test engineers and technicians during bench testing, environmental testing, and reliability studies.</li><li>Ensure accurate and timely execution of design verification and validation activities, including integration, performance, and system testing.</li><li>Oversee test data analysis, reporting, and documentation per good documentation practices (GDP).</li><li>Support root cause analysis and corrective actions for non-conformances or test failures.</li></ul><p><strong>Compliance and Documentation</strong></p><ul><li>Ensure all test documentation complies with FDA 21 CFR 820.30 (Design Controls), ISO 13485, and other applicable standards (e.g., IEC 60601, IEC 62304, ISO 14971, IEC 61010, ASTM, etc.).</li><li>Lead test method validation (TMV) and calibration documentation to ensure test integrity.</li><li>Support internal and external audits, design reviews, and regulatory submissions (510(k), CE marking).</li></ul><p><strong>Cross-Functional Collaboration</strong></p><ul><li>Partner with Design, Systems, Quality, Regulatory, and Manufacturing Engineering teams to ensure smooth transition from development to production.</li><li>Provide technical input for risk management, usability engineering, and design for manufacturability (DFM) activities.</li><li>Contribute to supplier and component qualification testing as needed.</li></ul><p><strong>Test Lab Oversight</strong></p><ul><li>Leads lab readiness and organization with support of R&D technicians and engineers – including, equipment calibration, maintenance, and supplies</li><li>Identifies, proposes, plans, and implements continuous improvements to enhance test lab capabilities for driving clinically relevant evaluations and real-world reliability improvements</li></ul><p>Requirements</p><p>  </p><p><strong>Education:</strong></p><ul><li>Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field.</li></ul><p><strong>Experience:</strong></p><ul><li>10+ years of experience in medical device development and testing</li><li>Proven experience with Class II medical devices regulated under FDA and ISO 900/9001, ISO 13485 etc.</li><li>Hands-on experience with electromechanical, optical, or fluidic medical systems preferred.</li><li>Strong familiarity with V&V, risk management, and design control processes.</li><li>Experience with CAD design</li><li>Working knowledge of basic statistics</li><li>Experience with data acquisition and analysis systems (Minitab, MATLAB) is a plus.</li></ul><p><strong>Technical Skills:</strong></p><ul><li>Proficiency in developing and executing test protocols, reports, and TMVs.</li><li>Understanding of regulatory standards: IEC 60601, ISO 14971, ISO 10993, IEC 61010, etc.</li><li>Experience in laboratory work and hands-on testing</li><li>Strong analytical, problem-solving, and data analysis skills.</li><li>Excellent documentation and communication skills.</li><li>Adept at managing multiple tasks, prioritizing and working with others</li></ul><p>  </p><p><strong>Soft Skills:</strong></p><ul><li>Demonstrated leadership and mentoring ability.</li><li>Strong collaboration across multidisciplinary teams.</li><li>Detail-oriented, highly organized, and proactive in identifying risks or gaps.</li><li>Comfortable working in a regulated environment with tight timelines.</li></ul><p>  </p><p><strong>Preferred Qualifications:</strong></p><ul><li>Experience with HF-OCT, catheter-based, or imaging medical devices.</li><li>Exposure to design transfer and manufacturing validation (IQ/OQ/PQ).</li><li>Experience supporting regulatory submissions (510(k), PMA, MDR).</li><li>Six Sigma Green Belt or equivalent process improvement certification.</li></ul>",
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    "requirements_html": "<p>&nbsp;&nbsp;</p><p><strong>Education:</strong></p><ul><li>Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field.</li></ul><p><strong>Experience:</strong></p><ul><li>10+ years of experience in medical device development and testing</li><li>Proven experience with Class II medical devices regulated under FDA and ISO 900/9001, ISO 13485 etc.</li><li>Hands-on experience with electromechanical, optical, or fluidic medical systems preferred.</li><li>Strong familiarity with V&amp;V, risk management, and design control processes.</li><li>Experience with CAD design</li><li>Working knowledge of basic statistics</li><li>Experience with data acquisition and analysis systems (Minitab, MATLAB) is a plus.</li></ul><p><strong>Technical Skills:</strong></p><ul><li>Proficiency in developing and executing test protocols, reports, and TMVs.</li><li>Understanding of regulatory standards: IEC 60601, ISO 14971, ISO 10993, IEC 61010, etc.</li><li>Experience in laboratory work and hands-on testing</li><li>Strong analytical, problem-solving, and data analysis skills.</li><li>Excellent documentation and communication skills.</li><li>Adept at managing multiple tasks, prioritizing and working with others</li></ul><p>&nbsp;&nbsp;</p><p><strong>Soft Skills:</strong></p><ul><li>Demonstrated leadership and mentoring ability.</li><li>Strong collaboration across multidisciplinary teams.</li><li>Detail-oriented, highly organized, and proactive in identifying risks or gaps.</li><li>Comfortable working in a regulated environment with tight timelines.</li></ul><p>&nbsp;&nbsp;</p><p><strong>Preferred Qualifications:</strong></p><ul><li>Experience with HF-OCT, catheter-based, or imaging medical devices.</li><li>Exposure to design transfer and manufacturing validation (IQ/OQ/PQ).</li><li>Experience supporting regulatory submissions (510(k), PMA, MDR).</li><li>Six Sigma Green Belt or equivalent process improvement certification.</li></ul>",
    "requirements_text": "Education:\n Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field.\n Experience:\n 10+ years of experience in medical device development and testing\n Proven experience with Class II medical devices regulated under FDA and ISO 900/9001, ISO 13485 etc.\n Hands-on experience with electromechanical, optical, or fluidic medical systems preferred.\n Strong familiarity with V&V, risk management, and design control processes.\n Experience with CAD design\n Working knowledge of basic statistics\n Experience with data acquisition and analysis systems (Minitab, MATLAB) is a plus.\n Technical Skills:\n Proficiency in developing and executing test protocols, reports, and TMVs.\n Understanding of regulatory standards: IEC 60601, ISO 14971, ISO 10993, IEC 61010, etc.\n Experience in laboratory work and hands-on testing\n Strong analytical, problem-solving, and data analysis skills.\n Excellent documentation and communication skills.\n Adept at managing multiple tasks, prioritizing and working with others\n Soft Skills:\n Demonstrated leadership and mentoring ability.\n Strong collaboration across multidisciplinary teams.\n Detail-oriented, highly organized, and proactive in identifying risks or gaps.\n Comfortable working in a regulated environment with tight timelines.\n Preferred Qualifications:\n Experience with HF-OCT, catheter-based, or imaging medical devices.\n Exposure to design transfer and manufacturing validation (IQ/OQ/PQ).\n Experience supporting regulatory submissions (510(k), PMA, MDR).\n Six Sigma Green Belt or equivalent process improvement certification."
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