Senior/Staff R&D Engineer - Reliability

Gentuity•Sudbury, MA

About The Position

This role focuses on leading the Design Verification and Validation (V&V) plan for medical devices, ensuring compliance with regulatory and quality system requirements. The engineer will define test strategies, oversee test execution, manage test documentation, and collaborate with cross-functional teams. Responsibilities include developing test plans, validating test fixtures, supervising test engineers, ensuring data integrity, and supporting root cause analysis. The position also involves ensuring compliance with various regulatory standards and supporting regulatory submissions. Additionally, the role includes oversight of the test lab, including equipment calibration, maintenance, and continuous improvement initiatives to enhance lab capabilities for clinically relevant evaluations and real-world reliability improvements.

Requirements

Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field.
10+ years of experience in medical device development and testing.
Proven experience with Class II medical devices regulated under FDA and ISO 900/9001, ISO 13485 etc.
Hands-on experience with electromechanical, optical, or fluidic medical systems preferred.
Strong familiarity with V&V, risk management, and design control processes.
Experience with CAD design.
Working knowledge of basic statistics.
Experience with data acquisition and analysis systems (Minitab, MATLAB) is a plus.
Proficiency in developing and executing test protocols, reports, and TMVs.
Understanding of regulatory standards: IEC 60601, ISO 14971, ISO 10993, IEC 61010, etc.
Experience in laboratory work and hands-on testing.
Strong analytical, problem-solving, and data analysis skills.
Excellent documentation and communication skills.
Adept at managing multiple tasks, prioritizing and working with others.
Demonstrated leadership and mentoring ability.
Strong collaboration across multidisciplinary teams.
Detail-oriented, highly organized, and proactive in identifying risks or gaps.
Comfortable working in a regulated environment with tight timelines.

Nice To Haves

Experience with HF-OCT, catheter-based, or imaging medical devices.
Exposure to design transfer and manufacturing validation (IQ/OQ/PQ).
Experience supporting regulatory submissions (510(k), PMA, MDR).
Six Sigma Green Belt or equivalent process improvement certification.

Responsibilities

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).
Define test strategies, protocols, and acceptance criteria for mechanical, electrical, optical, and system-level performance.
Ensure traceability of test activities to design inputs, risk controls, and user needs in collaboration with Systems and Quality teams.
Create and maintain test master plans, schedules, and resource allocation for multiple device programs.
Lead the development, validation, and maintenance of test fixtures, setups, and custom test equipment.
Supervise and mentor test engineers and technicians during bench testing, environmental testing, and reliability studies.
Ensure accurate and timely execution of design verification and validation activities, including integration, performance, and system testing.
Oversee test data analysis, reporting, and documentation per good documentation practices (GDP).
Support root cause analysis and corrective actions for non-conformances or test failures.
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.).
Lead test method validation (TMV) and calibration documentation to ensure test integrity.
Support internal and external audits, design reviews, and regulatory submissions (510(k), CE marking).
Partner with Design, Systems, Quality, Regulatory, and Manufacturing Engineering teams to ensure smooth transition from development to production.
Provide technical input for risk management, usability engineering, and design for manufacturability (DFM) activities.
Contribute to supplier and component qualification testing as needed.
Leads lab readiness and organization with support of R&D technicians and engineers – including, equipment calibration, maintenance, and supplies.
Identifies, proposes, plans, and implements continuous improvements to enhance test lab capabilities for driving clinically relevant evaluations and real-world reliability improvements.