Senior Process Development Engineer - Catheter

Job Type :

• Contract or Direct Hire Job Summary 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.
• Key Responsibilities 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.
• Qualifications 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.
• Physical Requirements 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.

Pay :