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 Manufacturing Engineer 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.
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:
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 Qualifications:
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
Relocation: This position is not eligible for relocation assistance.
Annual Salary Range: $118,800 – 149,700. Actual salaries will vary based on several factors including, but not limited to applicable work experience, training, education, performance.
This position is eligible for annual incentive plan based 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, paid leaves (including paid parental leave) and more.
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
#LI-Hybrid
Equal Opportunity Employer, including Disability and Veterans
Employment opportunities for positions in the United States may require use of information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States.
Donaldson Company has been made aware that there are several recruiting scams that are targeting job seekers. These scams have attempted to solicit money for job applications and/or collect confidential information, Donaldson will never solicit money during the application or recruiting process. Donaldson only accepts online applications through our Careers | Donaldson Company, Inc. website and any communication from a Donaldson recruiter would be sent using a donaldson.com email address. If you have any questions about the legitimacy of an employment opportunity, please reach out to [email protected] to verify that the communication is from Donaldson.
Our policy is to provide 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.
Donaldson Company Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Donaldson Company and has not been reviewed or approved by Donaldson Company.
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Retirement Support — Retirement programs like a 401(k) match, profit-sharing, and an employee stock purchase plan are positioned as meaningful components of total compensation. Company materials consistently frame retirement benefits within a broader Total Rewards offering.
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Healthcare Strength — Medical, dental, vision, and a 24/7 Employee Assistance Program with mental‑health resources create a comprehensive health and wellbeing package. Healthcare is often characterized as decent and a core strength of the overall offering.
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Leave & Time Off Breadth — Paid time off, holidays, and paid parental leave are explicitly included, alongside other company‑paid leaves such as bereavement, jury duty, and military leave. Some locations highlight multi‑week PTO from the first year, underscoring breadth of leave options.
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What We Do
Donaldson Company helps solve some of the world's most complex filtration and contamination control challenges, and is one of the largest global providers of unique filtration technologies and high-quality filters and parts. Our filtration technologies and products are used every day, in a variety of industries and environments, including aerospace, agriculture, construction, food and beverage, manufacturing, mining, power generation, transportation and many more. Key to our success, our 14,000 employees support customers at sales, manufacturing and distribution centers from over 140 locations on six continents. The filtration market continues to grow. Customers' needs for filtration solutions continue to evolve. And the opportunities for our products and our people continue to expand.
