Catheter Process Development Engineer II

Position Summary

The Catheter Process Development Engineer II will develop optimize and commercialize robust manufacturing processes for catheter assemblies and similar interventional medical components. As an Engineer II you will be working within a cross-functional product development team driving process innovation ensuring designformanufacturability and executing the required engineering deliverables to support successful design transfer and commercial release. The ideal candidate brings handson problemsolving ability strong analytical and experience with catheter or vascularaccess device manufacturing technologies.

We are open to hiring at an Engineer II or Engineer III level. This position will be based out of Fridley MN with travel to the White Bear Lake MN site to support project needs.

What Youll Do Every Day:

• 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 problemsolving and critical thinking to define process strategies resolve complex technical challenges and make datadriven decisions.
• Utilize engineering tools such as DOE pFMEA/PFMEA DFM principles capability studies and statistical analysis to characterize and improve processes.
• Develop clear wellsupported 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 handson 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 scaleup.
• Mentor junior engineers and interns; cultivate a culture of constructive feedback collaboration and continuous improvement.
• Support crossfunctional teams including Quality Manufacturing Supply Chain and Regulatory in preparing for commercialization and design transfer.
• Other duties may be assigned as required.

What Were Looking For:

• Bachelor degree in Engineering or related field required; masters 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 catheterspecific manufacturing equipment (braiding reflow tipping) materials (e.g. Pebax nylon PTFE liners and coatings) or bonding technologies.
• Proficiency in statistical analysis and datadriven 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.

Medevio is committed to providing competitive total compensation and benefits packages. The expected hiring range for this position is between $79000 and $115000 based upon a full-time schedule. This is a good faith estimate on the applicable salaries are determined by taking a variety of factors in account including but not limited to candidate qualifications geographic locations market conditions and internal position is bonus eligible with a target bonus of 10%.Our total compensation package includes eligibility for comprehensive medical dental and vision coverage a 401(k) plan with company match education reimbursement paid parental leave and paid time off.