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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Process Development Engineering for medical devices, utilizing statistical methods and Design of Experiments (DOE) to drive data-driven decisions. Proven ability to lead cross-functional teams, mentor engineers, and implement best practices in manufacturing processes.
Highest-signal resume keywords
Process Development EngineeringDesign of Experiments (DOE)Process ValidationManufacturing Experience in Medical DevicesLeadership in Continuous Improvement
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Process Development EngineeringDesign of Experiments (DOE)Process ValidationStatistical AnalysisTooling and Fixturing DevelopmentInstallation QualificationEngineering DeliverablesData-Driven Decision MakingMicro-Assembly TechniquesLaser Ablation/Welding/Marking
Soft Skills
MentoringCommunication of Technical ConceptsCross-Functional Relationship BuildingProblem SolvingInfluencing and Driving Results
Industry Keywords
Medical DevicesNew Product IntroductionManufacturing ProcessesTechnical DocumentationContinuous ImprovementFeedback CultureComplex Problem SolvingRegional CollaborationProduction Floor CollaborationTechnical Challenges
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Lead process design, development, and validation activities for medical devices through the product development process
- Determine solutions for complex problems, process selection decisions, and technical challenges
- Use Design of Experiments (DOE), pFMEA, DFM, and statistics for data-driven decisions
- Develop, implement, maintain, and document technical processes for new product introduction into manufacturing
- Lead tooling, fixturing, and equipment identification, procurement, and installation
- Drive documentation, qualification, or verification of tooling and equipment
- Create or leverage process validation protocols and engineering studies demonstrating technical rationale
- Mentor other engineers and promote a culture of feedback
- Collaborate with technicians and operators on the production floor to solve technical problems
- Establish regional relationships and collaborate to ensure best practices
- Perform other assigned duties
Requirements
What you’ll need- Bachelor degree in Engineering or related technical field strongly preferred; other relevant postsecondary education, training, and experience may be considered in lieu of a Bachelor’s degree
- Minimum 5 years of relevant experience required; 1 year of relevant experience may be substituted for a graduated degree and 3 years for a doctorate degree
- Manufacturing or Process Development experience in medical devices (delivery systems or catheters), micro-assembly, reflow, laser ablation/welding/marking highly desired
- Demonstrated knowledge of Process Development Engineering
- Ability to make complex data driven decisions utilizing statistics
- Experience with process validation, installation qualification, and engineering deliverables from the product development process
- Ability to identify, execute, and communicate on technical and/or project workstreams
- Ability to communicate complex technical concepts to senior management, production employees, and customers
- Demonstrated ability to develop cross-functional relationships and influence to drive results
- Strong leadership in communicating and championing continuous improvements and change
- Must be willing and able to travel between Fridley, MN and White Bear Lake, MN sites as needed
Benefits
Comp & perks- Bonus eligible, with a target bonus of 10%
- Comprehensive medical coverage
- Dental coverage
- Vision coverage
- 401(k) plan with company match
- Education reimbursement
- Paid parental leave
- Paid time off