Gentuity, LLC · 1 day ago
Test Engineer
Sudbury, MA
Full-time
Hybrid
Senior Level
5+ years expGentuity, LLC is seeking a Test Engineer to lead design verification, validation, and system-level testing for a Class II medical device. The role requires strong technical expertise in electromechanical and optical systems, ensuring compliance with regulatory standards and the device's intended clinical performance.
Health CareManufacturingMedical Device
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
Qualification
Required
Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field
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
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
Preferred
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
Company
Gentuity, LLC
Based in Sudbury, MA., Gentuity is a commercial-stage medical technology firm dedicated to developing next-generation intravascular imaging devices capitalizing on today’s best-in-class technologies.
51-200 employees
H1B Sponsorship
Gentuity, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
David W. Kolstad
Chief Executive Officer
Christopher Petersen
Co-founder and Senior Vice President
Recent News
2025-09-09
Medical Product Outsourcing
2025-08-13
Company data provided by crunchbase