Principal Process Development Engineer - Catheters & Delivery Systems

Principal Process Development Engineer - Catheters & Delivery Systems

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The Principal NPI/Process Development Engineer position leads the development, improvements and implementation of optimal cost‑effective designs and associated processes that meet the high rigor of product requirements and exceptional quality standards. This role will work specifically with complex catheters and delivery systems.

• Works independently to drive project completion by developing the processes used to manufacture component, sub‑assemblies, and FG devices.
• Provides leadership and mentors less experienced engineers and technicians.
• Acts as the liaison between development and operations.
• Advocates for the process to ensure they are repeatable and can capably produce product that meets the design requirements.
• Prepares and presents detailed plans necessary to complete assigned projects.
• Develops schedule milestones, coordinates resources, facility and equipment for assigned projects.
• Assists in improving the system of production controls, standard operating procedures, safety, quality control and training.
• Prepares and maintains detailed layouts of buildings and equipment.
• Coordinates the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results.
• Designs, develops and tests as well as sources various tools, machinery and equipment for recommended manufacturing methods while providing ROI analysis.
• Performs product/process analysis for production and quality metrics.
• Writes engineering change orders to process changes to manufacturing documents, drawing, and Bill of Materials.
• Supports company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.
• Recommends, supports and implements improvements, modifications or additions that will improve work processes.
• Takes the lead in analyzing the need for new process development and to meet company needs including specifying, ordering, installing and validating new equipment or processes.
• Prepares justification for capital expenditures.
• Aids in production transfers from R&D to manufacturing.
• Proposes potential new manufacturing technologies, including automation and new equipment.
• Contributes to the definition, development and implementation of LEAN manufacturing initiatives.

Education, Experience, Required Skills

• Bachelor’s degree in engineering or related field.
• 10+ years related experience in the medical device industry with a heavy focus on product and process development of catheter‑based delivery systems. Strongly preferred experience in neurovascular, structural heart, or peripheral balloon and steerable catheters. Experience with braided or coiled shafts, extrusion, bonding, lamination, hydrophilic coatings, and cleanroom manufacturing also considered.
• Extensive experience with process validations for catheter reflow, balloon forming, thermal bonding, and braid/coil reinforcement assembly, as well as DOE design, process characterization, and test method validation (e.g., burst, leak, tensile, and deflection testing).
• Demonstrated ability to independently develop medical device manufacturing processes from concept to production.
• Experience with medical device Design for Manufacturing, design control, quality systems and product development phases.
• Demonstrated ability to implement change in a way that positively impacts overall department and company performance.
• Must be able to handle multiple projects simultaneously.
• Must excel at working in a team environment with a high level of people/interpersonal skills and demonstrated ability to cross‑functionally drive results.
• Experience using influence to affect project and organizational success.
• Experience with programs including Solid Works and/or Mastercam.
• MS Office proficiency.
• Ability to handle and be trusted with confidential and/or sensitive information.

• Prolonged periods of sitting at a desk and working on a computer.
• Must…