Senior Verification & Validation Engineer — Med Devices

Cruxx; Edison (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Cruxx in Edison, NJ is hiring its first dedicated verification and validation engineer to build V&V for a complex electromechanical clinical device on a Class II pathway. You're hands-on, writing protocols, building test methods and fixtures, executing tests, and producing evidence of device compliance.

You will plan and perform V&V across mechanical, electrical, software, and system levels; design test plans, reports, traceability, and the DHF; collaborate with mechanical, software, and systems

Qualifications

• 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.

Responsibilities

• 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

Skills

V&V engineering

Medical device

Test protocol writing

System‑level testing

Documentation

Tools

Jama

Polarion

Job description

Cruxx in Edison, NJ is hiring its first dedicated verification and validation engineer to build V&V for a complex electromechanical clinical device on a Class II pathway. You're hands-on, writing protocols, building test methods and fixtures, executing tests, and producing evidence of device compliance.

You will plan and perform V&V across mechanical, electrical, software, and system levels; design test plans, reports, traceability, and the DHF; collaborate with mechanical, software, and systems