Principal Manufacturing Engineer (equipment Validation)

Donaldson

Bloomington, MN, US
$118,800 – 149,700; annual incentive plan based on...
Hybrid
Manufacturing process validation
Risk management deliverables
Design and process fmea
Donaldson is seeking a Principal Manufacturing Engineer (Equipment Validation) to lead validation functions in manufacturing processes for medical devices and bioprocessing systems. The ideal candidate will have extensive experience in engineering and compliance with regulatory requirements, particularly in the medical device sector

Job Summary

  • Donaldson is committed to solving the world’s most complex filtration challenges and is searching for an experienced Principal Manufacturing Engineer (Equipment Validation) to lead manufacturing process validation functions.
  • Responsible for validating manufacturing processes and systems meeting regulatory and quality requirements for Donaldson Life Sciences, partnering cross-functionally to define product requirements and ensure manufacturability.
  • This position is eligible for an annual incentive plan based on performance and company growth, and offers a comprehensive benefits program including health benefits and a retirement plan (401k).

Matching Summary

Match Score: 85

Donaldson is seeking a Principal Manufacturing Engineer (Equipment Validation) to lead validation functions in manufacturing processes for medical devices and bioprocessing systems. The ideal candidate will have extensive experience in engineering and compliance with regulatory requirements, particularly in the medical device sector.

Salary

$118,800 – 149,700; Annual incentive plan based on performance and company growth; Health benefits, retirement plan (401k), paid time away, paid leaves

Skills & Requirements

Must-have

  • Manufacturing process validation
  • Risk Management deliverables
  • Design and Process FMEA
  • Product Hazard Analysis
  • Design V&V
  • Design Transfer
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Test Method Development and Validation
  • FDA requirements
  • ISO 13485
  • ISO 9001
  • ISO 14971
  • IEC 62304

Nice-to-have

  • Collaboration and innovation culture
  • Statistical tools and software utilization
  • Design of Experiment (DOE)
  • Six Sigma methodology
  • Experience with external audits
  • Strong communication skills

Key Requirements

  • Bachelor's degree with Engineering focus
  • 10+ years of experience in Engineering
  • 5+ years of experience in IQ, OQ & PQ validations
  • 5+ years of medical device experience
  • Master’s Degree with Engineering focus
  • 10+ years of experience in Process Validation, Equipment Validation or Equipment Engineering
  • Experience with Quality Management Systems
  • Design and Process Failure Mode Effects Analysis
  • Utilize statistical tools and software
  • Experience with external audits
  • Strong communication skills

Work Rights

Not specified

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