Catheter Process Development Engineer II

The Catheter Process Development Engineer II will develop, optimize, and commercialize robust manufacturing processes for catheter assemblies and similar interventional medical components.

Requirements

• Lead and support the development, characterization, and validation of manufacturing processes for medical devices and components
• Apply structured problem-solving and critical thinking to define process strategies, resolve complex technical challenges, and make data-driven decisions
• 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

Benefits

• Comprehensive medical, dental, and vision coverage
• 401(k) plan with company match
• Education reimbursement
• Paid parental leave
• Paid time off