Validation Engineer Job at Pinnacle Partners, Inc, Bloomington, IN

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  • Pinnacle Partners, Inc
  • Bloomington, IN

Job Description

TITLE : Validation Engineer

Comp: From $90,000-$100,000/yr

Location: Bloomington, IN

Our client is seeking immediate assistance in identifying a candidate for a Validation Engineer direct hire position in Bloomington, IN

Responsibilities:

  • Validate and implement robust manufacturing processes for medical device production.
  • Identify and define installation qualification requirements for equipment and fixtures.
  • Prepare detailed application validation reports in compliance with EUMDR and FDA regulations.
  • Perform and document verification testing to ensure process and product reliability.
  • Evaluate legacy processes and recommend improvements to enhance efficiency and effectiveness.
  • Analyze process inputs and outputs to drive data-informed decisions and process optimization.
  • Prepare technical documentation to support regulatory submissions for both EU and FDA markets.

Required Skills & Qualifications:

  • 2+ years of experience in a similar role in the medical device manufacturing space
  • Experience with EUMDR or FDA regulations

TERMS: This is a direct hire position that pays from $90,000-$100,000/yr. This company does offer benefits including health, dental, and vision insurance

Job Tags

Immediate start,

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