Process Development Engineer II
Minor Hotels Europe and Americas
full-time
Posted on:
Location Type: Hybrid
Location: Fridley • Minnesota • United States
Visit company websiteExplore more
Salary
💰 $79,000 - $115,000 per year
About the role
- Lead and support the development, characterization, and validation of manufacturing processes for medical devices and components throughout the product development lifecycle, with a likely focus on catheter related projects
- Apply structured problem‑solving and critical thinking to define process strategies, resolve complex technical challenges, and make data‑driven decisions.
- 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 (IQ/OQ/PQ), engineering studies, technical rationales, risk documentation, and process development reports.
- Own process development workstreams, including timeline management, technical execution, communication of status, and risk mitigation.
- Work hands‑on with production technicians and operators to diagnose issues, improve yields, and implement sustainable production solutions.
- Contribute to the selection and qualification of equipment, tooling, fixtures, and automation solutions to support manufacturing scale‑up.
- Mentor junior engineers and interns; cultivate a culture of constructive feedback, collaboration, and continuous improvement.
- Support cross‑functional teams including Quality, Manufacturing, Supply Chain, and Regulatory in preparing for commercialization and design transfer.
Requirements
- Bachelor degree in Engineering or related field required; master’s degree in engineering or related technical field preferred.
- Minimum 2 years of relevant experience required, 5 years of experience required for Engineer III; 1 year of relevant work experience may be substituted for a graduate degree and 3 years for a doctorate degree.
- Demonstrated knowledge of process development engineering and catheter‑specific manufacturing equipment (braiding, reflow, tipping), materials (e.g., Pebax, nylon, PTFE liners and coatings), or bonding technologies.
- 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.
- Ability to manage and communicate technical workstreams, provide technical leadership, and collaborate across functions.
- Strong communication skills, with the ability to convey complex concepts to diverse audiences including management, operators, and customers.
- Demonstrated leadership and commitment to continuous improvement.
- 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 validationIQ/OQ/PQ executionDOEpFMEADFM principlescapability studiescatheter-specific manufacturing equipmentbonding technologies
Soft Skills
critical thinkingproblem-solvingcommunicationtechnical leadershipcollaborationmentoringcontinuous improvementtimeline managementrisk mitigationconstructive feedback
Certifications
Bachelor degree in EngineeringMaster’s degree in engineeringDoctorate degree in related field