Process Development Engineer II – Catheters
Minor Hotels Europe and Americas
full-time
Posted on:
Location Type: Hybrid
Location: Fridley • Minnesota • United States
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Salary
💰 $79,000 - $115,000 per year
About the role
- Lead and support the development, characterization, and validation of manufacturing processes for medical devices
- Apply structured problem-solving and critical thinking to define process strategies and resolve complex technical challenges.
- Utilize engineering tools such as DOE, pFMEA/PFMEA, DFM principles, capability studies, and statistical analysis to characterize and improve processes.
- Develop clear, well-supported documentation including process validation protocols, engineering studies, and risk documentation.
- Own process development workstreams, including timeline management and communication of status.
- Work hands-on with production technicians to diagnose issues and implement sustainable production solutions.
Requirements
- Bachelor degree in Engineering or related field required; master’s degree preferred
- Minimum 2 years of relevant experience required, 5 years required for Engineer III
- Demonstrated knowledge of process development engineering and catheter-specific manufacturing equipment
- Proficiency in statistical analysis and data-driven decision making
- Experience with process validation, IQ/OQ/PQ execution, and engineering deliverables required for medical device development
- Strong communication skills, with the ability to convey complex concepts to diverse audiences.
- Must be willing and able to travel between White Bear Lake, MN and Fridley, MN sites, as needed.
Benefits
- Comprehensive medical, dental, and vision coverage
- 401(k) plan with company match
- Education reimbursement
- Paid parental leave
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
process development engineeringstatistical analysisprocess validationDOEpFMEADFM principlescapability studiesdata-driven decision makingIQ/OQ/PQ executionengineering deliverables
Soft Skills
structured problem-solvingcritical thinkingcommunication skillstimeline management
Certifications
Bachelor degree in EngineeringMaster’s degree in Engineering