Senior Process Development Engineer - Catheter

The Senior Process Development Engineer supports the development, optimization, and validation of manufacturing processes for complex catheter-based delivery systems. The role focuses on post–design-freeze activities such as tooling, fixtures, process characterization, and validation (IQ/OQ/PQ). This engineer serves as a subject-matter expert on cross-functional teams and drives scalable, high-quality production processes.

• Develop and validate manufacturing processes for catheter-based delivery systems (e.g., reinforced shafts, balloons, steerable components).

• Lead process optimization activities, including DOE studies and data analysis.

• Create tooling, fixtures, and equipment strategies to improve process efficiency and operator usability.

• Support smooth transfer of designs into stable, validated production processes.

• Prepare process development plans, documentation, and validation protocols (IQ/OQ/PQ).

• Drive improvements in production controls, safety, training, and quality systems.

• Support cross-functional activities including operations, quality, program management, and documentation updates (ECOs).

• Participate in manufacturing readiness and gate reviews.

• Bachelor’s degree in engineering or related field.

• 5+ years of experience in process or product development.

• Hands-on experience with catheters, balloons, shafts, or similar component manufacturing.

• Strong understanding of DFM, design controls, statistical analysis, and validation methods.

• Proficiency in SolidWorks or similar tools and general MS Office programs.

• Ability to manage multiple projects and collaborate across teams.

• Ability to work at a computer for extended periods.

• Ability to lift up to 25 lbs when needed.

• Good hand–eye coordination and visual differentiation of small components.

• Ability to wear appropriate cleanroom attire when required.