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Donaldson · 22 hours ago

Principal Engineer (Equipment Validation)

Bloomington, MN (USA)

Full-time

Hybrid

Senior Level, Lead/Staff

$119K/yr - $150K/yr

10+ years exp

Donaldson is committed to solving the world’s most complex filtration challenges. We are searching for an experienced Principal Engineer - Equipment Validation to lead manufacturing process validation functions within new product development and lifecycle of medical devices and bioprocessing systems.

IndustrialIndustrial EngineeringLogisticsManufacturingMechanical EngineeringVirtual Reality

No H1B

Responsibilities

Lead manufacturing process validation functions within new product development, product line transfers, and lifecycle of medical devices and bioprocessing systems

Perform Risk Mgmt. Deliverables to include Design and Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis

Support design control deliverables to include product design specifications, design verification and design validation, (Design V&V), Design Transfer, Usability

Guide and support manufacturing process validation (Installation Qualification, Operational Qualification, and Performance Qualification)

Provide support for Variable and Attribute Test Method Development and Validation

Navigate government and quality regulations to include FDA requirements including 21 CFR Part 820, ISO 13485, ISO 9001, ISO 14971 and IEC 62304

Responsible for ongoing validation of manufacturing lines

Qualification

Process ValidationEquipment ValidationMedical Device ExperienceRisk ManagementQuality Management SystemsStatistical ToolsCommunication Skills

Required

Bachelor's degree with Engineering focus

10+ years of experience in Process Validation, Equipment Validation or Equipment Engineering

5+ years of experience in IQ, OQ & PQ validations

5+ years of medical device experience

Preferred

Master's Degree with Engineering focus (Mechanical, Electronics, Industrial or Biomedical Engineering or Engineering Management or related engineering field.)

Experience with Quality Management Systems (ISO 13485, ISO 9001, and/or ISO 14971)

Design and Process Failure Mode Effects Analysis

Utilize statistical tools and software to include Design of Experiment (DOE), Confidence and Tolerance Limits, Gage R&R, Capability analysis and Six Sigma methodology in auditing and ensuring quality and reliability outcomes

Experience with external audits

Strong communication skills, including customer interactions