Design Quality Engineer - Risk File Remediation

Job Description
Insight Global is seeking a Senior Design Quality Engineer (DQE) to support risk management file remediation efforts for a medical device product line of one of our Medical Device clients. This consultant will lead end‑to‑end remediation of risk files to ensure alignment with ISO 14971 and regulatory expectations. This role requires a highly independent Design Quality professional who can take full ownership of risk documentation, facilitate cross‑functional PFMEA sessions, and drive alignment across Engineering, Quality, and Regulatory stakeholders. While the role is largely remote, candidates with proximity to Livingston, NJ or Trumbull, CT sites will be preferred due to faster product familiarization.

They will own and execute full remediation of product risk management files, including:
Risk Management Plans
Hazard Analyses
Risk Management Reports
DFMEAs and Use‑Related FMEAs

Review existing risk documentation, identify gaps, and upd...