Senior Product Test Engineer

Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end‑to‑end professional services firm focused on Med Tech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.

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.

• 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 non‑conforming 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.

• 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 Solid Works.
• 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.

• 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.

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social or ethnic origin, or any other applicable legally protected characteristics.