Associate Validation Engineer

Location: Danvers, MA (100% onsite) – Long-term contract (18+ months).

About the Role

Seeking an experienced Associate Validation Engineer to support a large-scale Medical Device Remediation Program. The role involves executing IQ/OQ/PQ, Process Validation, Equipment Qualification, Test Method Validation (TMV), and Inspection Validation within an FDA-regulated manufacturing environment while collaborating with Quality, Manufacturing, and Engineering teams.

Requirements

• 5–8 years of Medical Device Validation experience
• Bachelor’s Degree in Electrical or Mechanical Engineering
• Strong experience with:
  • IQ/OQ/PQ
  • Process Validation
  • Equipment Qualification
  • Test Method Validation (TMV)
  • Inspection Method Validation
• Knowledge of FDA Quality Systems & ISO standards
• Excellent technical documentation and reporting skills

Preferred Skills

• Electrical focus: electronics manufacturing, soldering, inspection equipment validation
• Mechanical focus: manufacturing process validation, assembly validation, soldering experience