Manufacturing / Quality Engineers – Medical Device (Onsite)

Manufacturing / Quality Engineers – Medical Device (Onsite)
Newark, Delaware 100% on site.
6 - 12 months contract
 
Start: ASAP, staggered starts. The sooner they can start the better. 
 
Overview
 
We are partnering with a leading medical device organization to build out a high-impact engineering team supporting their flagship mammography systems. This is a critical initiative focused on strengthening the foundation of their Quality Management System and driving validation excellence across manufacturing operations.
 
Must-Have Background
4–5+ years medical device experience (minimum)
Engineering degree required (Mechanical, Biomedical, Industrial, etc.)
Experience at established med device companies (e.g., Stryker, J&J, etc.)
Prior remediation experience strongly preferred
Strong validation and TMV experience
 
Day to Day
Review and enhance existing PFMEAs, Identify missing failure modes and risk gaps, strengthen mitigations and ensure appropriate controls are in place (PFMEA assessment, development, and remediation). 
Conduct thorough process risk analysis, drive root cause investigations and implement corrective actions.
Lead and execute validation activities (IQ/OQ/PQ), develop and defend validation strategy and protocols, execute and document TMV activities
Manage deviations, link risks appropriately, and ensure regulatory alignment
Collaborate cross-functionally with manufacturing, quality, and program management stakeholders
______________
 
Additional Feedback: 
Doesnt like to se resumes filled with buzzwords (ChatGPT-polished) but lacking technical depth.
Interview focus will include: 
“Walk me through a complicated validation you personally led.”
Deep dive on:
Protocol development
Acceptance criteria
Risk linkage
Deviations & root cause
Regulatory impact