About the role

Catheter Process Development Engineer II at Heraeus developing and optimizing manufacturing processes for medical devices. Leading continuous improvement initiatives and collaborating with cross-functional teams for successful product development.

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.

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.