Job Description

Medical Device V&V Engineer

On-site, Edison, NJ

A MedTech company in Edison, NJ is hiring its first dedicated verification and validation engineer. They're building a complex electromechanical system for clinical use, on a Class II pathway, and the V&V function doesn't exist yet. You'd be the person who builds it.

This is a hands-on individual contributor role. There's no V&V team to manage and no library of protocols to inherit. You write the protocols, build the test methods and fixtures, run the tests, and produce the evidence that the machine does what it claims. If you want a fully staffed quality organisation around you from day one, this isn't it. If you want to set the standard rather than follow one, keep reading.

What you will do

• Plan and execute design verification and validation across a complex electromechanical device: mechanical, electrical, software and the system as a whole
• Write and run protocols, design test methods and fixtures, and document everything to a regulated standard
• Own the V&V documentation end to end: test plans, reports, traceability, and the DHF content that comes from them
• Help shape and improve an internal tool the company is building to speed up documentation workflows, so the process gets faster without getting looser
• Work directly with the mechanical, software and systems engineers, so the whole machine is provably right, not just the parts
• Keep pace with a team that iterates in days, without dropping rigour

Who you are

• 5+ years in medical device verification and validation, ideally including a Class II device through to clearance
• Hands-on protocol writing and execution. You've done the work yourself, not just managed the programme
• Comfortable working across the system level: electromechanical hardware, embedded or application software, and how they behave together
• Fluent in 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304, with a working grasp of requirements traceability and risk management
• You see documentation as the product of good engineering, not a chore that follows it
• Comfortable in a fast-moving, low-volume, pre-commercial environment where process is still being written

Nice to have

• Experience as the first or only V&V engineer somewhere
• Test fixture design and build
• Familiarity with Jama, Polarion or similar requirements and test management tools
• Exposure to AI-assisted or automated documentation tooling

What this is not

• A quality assurance, regulatory affairs or quality systems role
• Manufacturing validation, cleaning validation, CQV or computer system validation
• A programme management seat overseeing other people's testing

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