Tekhawks

Associate Validation Engineer  Mechanical Focus

Location: Danvers, MA

Schedule: 100% Onsite

These are the top requirements:

Air Quality
Visual Inspection
Air Filtration
Water Filtration

Position Summary

Seeking an Associate Validation Engineer to support medical device validation activities within a manufacturing and remediation environment. This role will support process validation, test method validation, inspection validation, and equipment qualification activities while working closely with Quality, Engineering, Manufacturing, and Operations teams.

The ideal candidate will possess a strong engineering foundation (Electrical or Mechanical) along with hands-on experience supporting validation activities within a regulated medical device environment.

Responsibilities

• Execute IQ, OQ, and PQ protocols
• Support process validation and equipment qualification activities
• Develop and execute test method validation (TMV) protocols
• Support inspection method validation activities
• Assist with validation protocol generation, execution, and reporting
• Support root cause investigations associated with validation activities
• Review and analyze validation data
• Collaborate with Quality, Manufacturing, and Engineering teams
• Support remediation and continuous improvement initiatives
• Maintain validation documentation in accordance with FDA and ISO requirements

Required Qualifications

• Bachelor's degree in Engineering (Electrical or Mechanical preferred)
• 5-8 years of medical device validation experience
• Experience with:
• • IQ/OQ/PQ
  • Process Validation
  • Test Method Validation (TMV)
  • Inspection Method Validation
• Working knowledge of FDA Quality System requirements
• Strong technical writing and documentation skills

Mechanical Opening

• Mechanical Engineering background
• Manufacturing process validation experience
• Prior soldering experience
• Assembly process validation