Share Email Opening Apply Now Title Process Development Engineer  EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.   About the Organization We are a dedicated and multidisciplinary group of problem solvers with decades of engineering expertise. As a leader in complex catheter development we have assembled a team of world class engineers that don't shy away from challenges.   Position Process Development Engineer (Technologies)   Description Process Development Engineer - Technologies The Process Development Engineer is responsible for developing, documenting, validating, and continuously improving processes supporting balloon manufacturing, injection molding, 3D printing, and pad printing technologies. This role serves as the technical owner for assigned manufacturing technologies and partners closely with Operations, Quality, Engineering, and Production to ensure safe, efficient, and repeatable manufacturing processes that meet quality and regulatory requirements. Reporting to the Technologies Manager, this position combines hands-on technical work in the clean room with documentation, process development, tooling design, and operator training. Duties and Responsibilities Develop, optimize, and sustain manufacturing processes for balloon manufacturing, injection molding, and pad printing. Author and maintain SOPs, work instructions, manufacturing specifications, and other controlled documentation. Design and build manufacturing tooling and fixtures to improve quality, efficiency, and repeatability. Lead process qualification activities, including equipment qualification and IQ/OQ/PQ protocol development and execution. Support engineering change activities through DCRs, ECOs, and related documentation. Analyze manufacturing data to identify trends, improve yield, reduce scrap, and increase process capability. Train production operators and technicians on manufacturing processes, equipment, and best practices. Troubleshoot manufacturing equipment and process issues to minimize downtime. Collaborate with Quality to investigate nonconformances, implement CAPAs, and support root cause analysis. Participate in new product introduction and technology transfer into manufacturing. Ensure compliance with ISO 13485, FDA Quality System Regulation, and internal quality procedures. Support continuous improvement initiatives across manufacturing technologies. Maintain documentation supporting process validation and manufacturing readiness. Assist with equipment setup, qualification, and ongoing process monitoring. Other duties as assigned.   Position Requirements Education, Experience, Skills Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, Engineering Technology, or a related technical field, or equivalent combination of education and relevant experience. Experience supporting manufacturing processes in a regulated environment. Experience developing controlled manufacturing documentation. Familiarity with engineering change processes (DCRs/ECOs). Experience designing tooling or fixtures. Strong mechanical aptitude and troubleshooting skills. Excellent technical writing and communication skills. Preferred Skills Medical device manufacturing experience. Experience with balloon manufacturing, catheter manufacturing, injection molding, or pad printing. Experience with process validation (IQ/OQ/PQ). Knowledge of ISO 13485 and FDA Quality System Regulations. Experience using SolidWorks or similar CAD software. Familiarity with statistical analysis and process capability methods. Experience training manufacturing personnel.   Compensation & Benefits Salary range: $75,000 - $120,000 The following benefits are available to full-time employees: Flexible PTO & sick time 9 paid company holidays Health, Dental, & Vision coverage Short- & Long-Term Disability opt-in Health Savings Account (HSA) & employer contribution 401(k) & employer contribution   Exempt/Non-Exempt Non-Exempt   Full-Time/Part-Time Full-Time   Open Date 7/30/2026   This position is currently accepting applications. Apply Now WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles Quality Inspector Technician in Maple Grove, MN Posted on: 7/14/2026 [Apply Now]

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