Principal Engineer; Equipment Validation

Donaldson is committed to solving the world’s most complex filtration challenges. We are continuously evolving to meet the changing world’s filtration needs. Join a culture of collaboration and innovation that matters and learn, effect change, and make meaningful contributions at work and in communities.

Principal Engineer – Equipment Validation

Location:

Bloomington, MN (hybrid schedule)

• Lead manufacturing process validation functions within new product development, product line transfers, and lifecycle of medical devices and bioprocessing systems.
• Perform risk management deliverables including Design and Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis.
• Support design control deliverables: product design specifications, design verification and validation (Design V&V), design transfer, and 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, including FDA requirements (21 CFR Part 820), ISO 13485, ISO 1, ISO 14971, and IEC 62304.
• Responsible for ongoing validation of manufacturing lines.

• Bachelor’s degree with an 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.

• Master’s degree with an engineering focus (Mechanical, Electronics, Industrial, Biomedical Engineering, Engineering Management, or related).
• Experience with Quality Management Systems (ISO 13485, ISO 9001, ISO 14971).
• Expertise in Design and Process Failure Mode Effects Analysis.
• Proficiency with statistical tools and software such as Design of Experiment (DOE), Confidence and Tolerance Limits, Gage R&R, Capability analysis, and Six Sigma methodology.
• Experience with external audits.
• Strong communication skills, including customer interactions.

Up to 25%

This position is not eligible for relocation assistance.

$118,800 – $149,700 (actual salaries will vary based on experience, training, education, performance).

Our comprehensive benefits program includes health benefits, retirement plan (401(k)), paid time away, paid leaves (including paid parental leave) and more.

Applicants must be currently and legally authorized to work in the United States without the need for current or future sponsorship. Donaldson will not offer immigration sponsorship or assume sponsorship of an employment visa.

equipment validation, engineer, medical devices, life sciences, process validation, new test development, qualification validation

Donaldson Company, Inc. is an Equal Opportunity Employer, including Disability and Veterans. The Company provides equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.