Senior R&D Engineer- Systems - Medical Device -#0566

Location Marlborough, MA,Marlborough, MA, 01752,United States Employee Type Contractor or FT Employee Required Degree 4 Year Degree About the Role ECI is seeking a Senior Systems TMV (Test Method Validation) Engineer to support our client's project team, including software and electromechanical engineers, with the full review of their existing test methods, evaluating current TMs for gaps in structure, clarity, measurement criteria, and validity including the rewriting and restructuring of existing TMs so they are standalone, repeatable, and validation ready. The role will also support performing measurement system analysis (Gage R&R) to demonstrate repeatability and reproducibility of each validated TM. What We Look For Experience reviewing and redeveloping existing test methods (TMs) in medical device environments. Strong understanding of systems-level testing for electromechanical and software integrated devices. Hands-on experience executing TMV protocols, running validation studies to demonstrate TM repeatability, accuracy, and robustness Proficient in Gage R&R and measurement system analysis (MSA), designing and executing R&R studies across operators and equipment Able to assess existing TMs for gaps in setup instructions, fixtures, calibration requirements, acceptance criteria, measurement units, and operator instructions Experience aligning test methods to existing design verification, adjusting TMs to fit DV/DVal rather than requiring reverification Familiar with risk-based prioritization of TMs (helping determine which TMs need full validation vs. which are standard or self-evident) Deep familiarity with design controls, DHF deliverables, and risk management (ISO 14971, FMEA) Experience working in QMS remediation or post-warning letter environments Able to coordinate across software, electrical, and mechanical teams to ensure system-level TM coverage About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity. #J-18808-Ljbffr Theuniversityunion