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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Manufacturing Process Development for medical devices, utilizing statistical methods and Design of Experiments to drive data-driven decisions. Proven ability to lead cross-functional teams, mentor engineers, and implement best practices in product development and process validation.
Highest-signal resume keywords
Manufacturing Process DevelopmentProcess ValidationDesign of Experiments (DOE)Technical LeadershipCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process Development EngineeringData-Driven Decision MakingTooling and Fixturing DesignInstallation QualificationEngineering DeliverablesMicro-AssemblyReflowLaser AblationStatistical AnalysisProcess Selection
Soft Skills
MentoringCommunicationLeadershipInfluencingContinuous Improvement
Industry Keywords
Medical DevicesProduct Development ProcessTechnical ProcessesComplex Problem SolvingFeedback Culture
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Create robust and sustainable manufacturing processes for medical components and devices
- Provide technical leadership for commercial release of products to production through the Medevio product development process
- Lead process design, development, and validation activities for medical devices
- Determine solutions for complex problems, process selection decisions, and technical challenges
- Use Design of Experiments (DOE), pFMEA, DFM, and statistics to make data-driven decisions
- Develop, implement, maintain, and document technical processes for new product introduction into manufacturing
- Lead tooling, fixturing, and equipment identification, procurement, installation, documentation, qualification, and verification
- 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 are utilized
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
- Able to make complex data driven decisions utilizing statistics
- Experience with process validation, installation qualification, and engineering deliverables from the product development process
- Able to identify, execute, and communicate on technical and/or project workstreams
- Able 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 continued 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
