Senior/Staff R&D Engineer - Reliability

Gentuity, LLC.; Sudbury (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Gentuity, LLC. is seeking a skilled professional to develop and lead design verification and validation (V&V) strategies for medical devices. This role entails ensuring compliance with regulatory standards, overseeing the execution of test activities, and maintaining documentation integrity.

The ideal candidate will have over 10 years of experience in medical device development, particularly with Class II devices, and demonstrate strong leadership in cross-functional collaboration.

Qualifications

• 10+ years of experience in medical device development and testing.
• Proven experience with Class II medical devices regulated under FDA.
• Hands-on experience with electromechanical, optical, or fluidic systems.

Responsibilities

• Develop and lead V&V plans compliant with regulatory requirements.
• Execute design verification and validation activities.
• Oversee test data analysis and documentation.

Skills

Test protocol development

Collaboration

Risk management

Data analysis

Regulatory compliance

Education

Bachelor’s or Master’s in Biomedical Engineering

Tools

Minitab

MATLAB

Job description

Description

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.

Test Lab Oversight

• 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

Requirements

Education

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

Experience

• 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.

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.