ECI - Medical Device - Senior Software TMV Engineer

Brief Description

About The Role

ECI is seeking a Senior Systems TMV (Test Method Validation) Engineer to support our client's project team, including system and electromechanical engineers, with the full review of their existing test methods, evaluating current TMs for gaps in structure, clarity, measurement criteria, and validatability 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 (Gauge R&R) to demonstrate repeatability and reproducibility of each validated TM.

What You'll Do

• Lead and execute software-related Test Method Validation (TMV) and Gauge R&R studies for products, systems, and software-enabled measurement processes.
• Design, develop, and validate test methods to ensure measurement accuracy, repeatability, reproducibility, and robustness.
• Establish statistical methodologies for Gauge R&R, measurement system analysis (MSA), capability studies, and data trending.
• Collaborate with Software Engineering and Quality teams to define validation protocols, acceptance criteria, and risk-based testing approaches.
• Develop and review TMV documentation including protocols, reports, traceability matrices, statistical analyses, and validation summaries.
• Support software verification and validation (V&V) activities, ensuring alignment with design controls and quality system requirements.
• Analyze software-generated measurement data to identify variability, root causes, and opportunities for process improvement.
• Ensure compliance with applicable industry standards, quality systems, and regulatory requirements (e.g., FDA, ISO, IEC, GxP as applicable).
• Provide technical leadership and mentorship to engineers on statistical methods, software validation strategies, and measurement system reliability.
• Partner with R&D, Manufacturing, Quality Assurance, and Regulatory Affairs teams to resolve validation issues and support product development and sustaining activities.
• Drive continuous improvement initiatives related to software testing methodologies, automation, and measurement system performance.

What We Look For

• Experience evaluating and redeveloping existing software test methods, reviewing current TMs for completeness, repeatability, and compliance, then restructuring them into validatable formats
• Background in medical device software V&V, preferably in diagnostic imaging, AI/ML-assisted detection, or image processing.
• Hands‑on experience executing software TMV, running validation protocols that prove software test methods produce consistent, reliable, and reproducible results
• Proficient in Gauge R&R / MSA as applied to software measurement outputs where applicable to quantitative software test outputs
• Strong experience with IEC 62304 (software lifecycle) and software verification and validation
• Familiarity with software risk management (IEC 62304 and ISO 14971) and cybersecurity considerations
• Experience with acquisition workstation testing and UI/UX validation.
• Comfortable in FDA‑regulated environments (21 CFR 820, PMA pathway)
• Must work closely with systems and electromechanical engineers for integrated TM alignment

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.