Principal Process Development Engineer - Catheter

The Principal Process Development / NPI Engineer leads the development and implementation of cost-effective product designs and manufacturing processes for complex catheter-based delivery systems. This role focuses on process innovation, scale-up, and ensuring high performance and quality during new product introduction.

• Lead development of processes for components, sub-assemblies, and finished devices.

• Mentor and guide engineers and technicians; provide technical leadership within project teams.

• Serve as the link between development and operations to ensure smooth manufacturing transfer.

• Drive creation of robust, repeatable processes that consistently meet design and quality requirements.

• Develop project plans, schedules, and resource requirements.

• Support improvements in production controls, SOPs, safety, quality, and training.

• Plan and maintain layouts for equipment and manufacturing areas.

• Lead manufacturing launches for new or updated products, including training and performance evaluation.

• Design or source tooling, fixtures, and equipment, including cost/ROI analysis.

• Analyze process capability, production efficiency, and quality metrics.

• Create and revise engineering change documentation (ECOs).

• Support cross-functional groups such as quality, operations, regulatory, and finance.

• Identify and implement process improvements and new technologies, including automation.

• Specify, purchase, install, and validate new equipment or processes.

• Prepare capital expenditure justifications.

• Support product transfer from development to manufacturing.

• Contribute to Lean initiatives and continuous improvement efforts.

• Bachelor’s degree in engineering or related field.

• 10+ years of experience in process or product development involving catheter-based or similar complex assemblies.

• Strong background in process validation, DOE, process characterization, and test method development.

• Proven ability to develop manufacturing processes from concept through production scale-up.

• Experience with DFM, design controls, quality systems, and structured development processes.

• Ability to manage multiple projects and drive cross-functional results.

• Strong interpersonal, communication, and influence skills.

• Proficiency with SolidWorks, Mastercam, and standard office software.

• Ability to handle sensitive or confidential information.

• Ability to sit and work at a computer for extended periods.

• Ability to lift up to 25 lbs as needed.

• Good hand–eye coordination and ability to distinguish small components.

• Ability to wear cleanroom-appropriate attire when required.