Heraeus · 5 hours ago
Catheter Process Development Engineer II
Fridley, MN
Full-time
Onsite
Mid, Senior Level
$79K/yr - $115K/yr
2+ years expHeraeus is a family-owned global technology group committed to improving lives through innovative medical devices. The Catheter Process Development Engineer II will develop and optimize manufacturing processes for catheter assemblies, working within a cross-functional product development team to drive innovation and ensure successful design transfer.
Advanced MaterialsElectronicsHardwareManufacturingPrecious MetalsSustainability
Responsibilities
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
Other duties may be assigned as required
Qualification
Required
Bachelor degree in Engineering or related field required
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
Preferred
Master's degree in engineering or related technical field preferred
Benefits
Comprehensive medical, dental, and vision coverage
A 401(k) plan with company match
Education reimbursement
Paid parental leave
Paid time off
Company
Heraeus
Heraeus is a holding company that produces precious metals, materials and technologies.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Rolf Wetzel
Group CFO
Christine Asher, SHRM-CP
Human Resources Business Partner
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