Associate Validation Engineer

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.

• sExecute IQ, OQ, and PQ protocol
• sSupport process validation and equipment qualification activitie
• sDevelop and execute test method validation (TMV) protocol
• sSupport inspection method validation activitie
• sAssist with validation protocol generation, execution, and reportin
• gSupport root cause investigations associated with validation activitie
• sReview and analyze validation dat
• aCollaborate with Quality, Manufacturing, and Engineering team
• sSupport remediation and continuous improvement initiative
• sMaintain validation documentation in accordance with FDA and ISO requirement

• ns Bachelor's degree in Engineering (Electrical or Mechanical preferre
• d)5-8 years of medical device validation experien
• ce Experience wit
• h:
  
  IQ/OQ/
• PQProcess Validati
• onTest Method Validation (TM
• V)
  Inspection Method Validati
• on Working knowledge of FDA Quality System require men
• ts Strong technical writing and documentation skil

ons Electrical Open

• ing Electrical Engineering backgro
• und Electronics manufacturing experie
• nce Soldering experie

• ing Mechanical Engineering backgro
• und Manufacturing process validation experie