About This Role

The Senior Product Test Engineer is responsible for developing, executing, and maintaining test methods, equipment, and procedures to ensure medical devices meet design specifications, quality standards, and regulatory requirements. This role partners closely with R&D, Quality, Manufacturing, and Regulatory teams to support verification and validation activities, manufacturing processes, and ongoing production testing in a highly regulated environment.

What You’ll Do

• Develop, validate, and document test methods and inspection procedures in compliance with FDA, ISO 13485, and internal quality system requirements.
• Execute verification and validation (V&V) activities for new product development and design changes.
• Perform root cause analysis and troubleshoot test failures, deviations, and nonconforming results.
• Design, create, and maintain test fixtures, jigs, and automated test systems to support R&D and production testing.
• Support production line testing, including calibration, maintenance, and optimization of test equipment.
• Collaborate with manufacturing engineering to implement process and test improvements that enhance product quality and test reliability.
• Lead or support equipment qualification activities (IQ/OQ/PQ).
• Author and maintain test protocols, reports, work instructions, and technical documentation.
• Ensure compliance with regulatory standards including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Support internal, customer, FDA, and ISO audits related to testing processes and equipment.
• Participate in risk management activities such as FMEA and hazard analysis.
• Provide engineering support for design reviews, CAPA investigations, and supplier quality discussions.
• Train technicians and operators on testing procedures and proper use of test equipment.
• Utilize tools such as LabVIEW, Python, MATLAB, or similar platforms to automate test processes.

Qualifications

Required

• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, Systems, or related discipline).
• Minimum of 5 years of experience in test engineering, validation, or quality engineering, preferably in medical devices or another regulated industry.
• Hands-on experience with test equipment such as oscilloscopes, multimeters, force gauges, sensors, and similar instrumentation.
• Strong experience in PCB and fixture design using Altium and SolidWorks.
• Experience designing and assembling test fixtures.
• Knowledge of statistical analysis and validation tools (e.g., Minitab, DOE, Gage R&R).
• Familiarity with FDA regulations, ISO 13485, ISO 14971, and good documentation practices.
• Experience with automated test systems and scripting or programming languages such as LabVIEW, Python, or MATLAB.
• Ability to work in lab and manufacturing environments, including cleanroom settings.
• Ability to lift up to 25 lbs. and stand for extended periods as needed.

• Hybrid role based in Providence, RI, requiring regular on‑site work.

Preferred

• Experience with electromechanical or disposable medical devices.
• Background in reliability engineering, accelerated life testing, or environmental testing.
• Working knowledge of GMP and cleanroom manufacturing practices.
• Prior experience supporting manufacturing transfers and production-scale testing.