Principal Engineer (Equipment Validation)

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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. Responsible for validating manufacturing processes and systems meeting regulatory and quality requirements for Donaldson Life Sciences. Partnering cross-functionally with product design groups manufacturing centers and other resources to define product requirements and ensure manufacturability of new designs over the program life cycle.

Your role is required to assure compliance of Donaldsons operations to all applicable laws regulations and standards good business practices and company documented procedures (including knowledge of all standards government occupational health and environmental regulations and statutes related to the site). Qualified candidates must be able to work a hybrid schedule at our Bloomington MN office.

Role 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.

Travel: Up to 25%

Minimum Qualifications:

• Bachelors 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 Qualifications:

• Masters 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

Relocation: This position is not eligible for relocation assistance.

Annual Salary Range:$. Actual salaries will vary based on several factors including but not limited to applicable work experience training education performance.

This position iseligible forannualincentive planbased on performance and company growth.

Employee benefits are part of the competitive total rewards package that Donaldson Company Inc. provides to you. Our comprehensive benefits program includes health benefits retirement plan (401k) paid time away paidleaves(including paid parental leave)andmore.

Immigration Sponsorship Not Available:

• Applicants for this position must be currently and legally authorized to work in the United States without the need for current or future sponsorship (e.g. H-1B J-1 F-1 CPT OPT etc.).

• Donaldson will not offer immigration sponsorship or assume sponsorship of an employment visa for this position.

• International relocation or remote work arrangements outside of the U.S. will not be considered.

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

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Equal Opportunity Employer including Disability and Veterans

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