Test Strategy and Planning

• 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.

Test Execution and Oversight

• 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.

Compliance and Documentation

• 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).

Cross-Functional Collaboration

• 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.

Education:

• Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field.

Experience:

• 5+ 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.

Technical Skills:

• 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

•

________________________________________

Soft Skills:

• 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.

________________________________________

Preferred Qualifications:

• 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.

EDUCATIONAL REQUIREMENTS:

B.S. or B.E. in the field of Mechanical Engineering, Biomedical Engineering, Physics or related.