Principal Process Development Engineer, Active Implantables
Overview
You will own the development and implementation of manufacturing processes for active implantable medical devices, including IPGs and Neuromodulation Devices, ensuring they meet rigorous quality standards. You will act as the bridge between R&D and operations, leading the transfer of new products from concept to production. Your work will directly impact the reliability and performance of life-changing devices. With 10+ years of experience, you will mentor junior engineers and drive process innovation in a collaborative, cross-functional environment.
What You'll Do9
- 1Develop and validate manufacturing processes for component, sub-assembly, and finished goods, using DFM principles and SolidWorks or Mastercam for design and tooling.
- 2Lead the manufacturing launch of new or revised products, setting goals, coordinating resources, and evaluating results to ensure smooth production ramp-up.
- 3Design, source, and validate new equipment and automation, including laser welding, header attachment, and helium leak testing systems, with ROI analysis for capital expenditures.
- 4Drive process improvements by analyzing production and quality metrics, implementing LEAN manufacturing initiatives, and writing engineering change orders to update documents, drawings, and BOMs.
- 5Collaborate with quality, regulatory, and clinical departments to ensure process compliance and support audits.
- 6Mentor less experienced engineers and technicians, fostering a culture of technical excellence and continuous improvement.
- 7Manage multiple projects simultaneously, prioritizing tasks and communicating status to stakeholders.
- 8Support production transfers from R&D to manufacturing, ensuring processes are repeatable and capable.
- 9Propose new manufacturing technologies and automation to enhance efficiency and quality.
Requirements9
- 110+ years in medical device process development, with a focus on Active Implantable Devices such as IPGs or Neuromodulation Devices.
- 2Bachelor's degree in engineering or related field.
- 3Extensive experience with process validations for laser welding, header attachment, and internal moisture (bake) and test method validation for Helium Leak Testing.
- 4Proven ability to independently develop manufacturing processes from concept to production in a medical device environment.
- 5Knowledge of Design for Manufacturing (DFM), design control, quality systems, and product development phases.
- 6Strong leadership skills, with a track record of mentoring and driving cross-functional results.
- 7Proficiency in SolidWorks and/or Mastercam, and MS Office.
- 8Excellent hand-eye coordination, ability to lift up to 25 pounds, and differentiate between colored wires and electronic components.
- 9Must be able to handle confidential information and work in a team environment.
Salary Insight
$135 - $185k per year
Location
Required Skills
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