Principal Engineer (Equipment Validation)

Donaldson•Bloomington, IN

2d•Hybrid

About The Position

Donaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make meaningful contributions at work and in communities. 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 Donaldson's 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.

Requirements

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

Nice To Haves

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

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.