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Process Development Engineer
2 months ago
We are seeking a highly skilled Process Development Engineer to join our team at Katalyst Healthcares & Life Sciences. As a key member of our process development team, you will be responsible for developing and implementing manufacturing processes that meet our high standards of quality and efficiency.
Key Responsibilities- Participate in or lead equipment and process development, process characterization, and process qualification to support new product introduction.
- Utilize functional excellence in process development, including DFM, process characterization, equipment development, Lean, and Six Sigma methodologies.
- Drive results on project teams through building relationships and strong technical decision-making.
- Partner with design engineering to identify design for manufacturability and assembly targets.
- Partner with purchasing to ensure all needed materials procurement per process development/validation/training needs and the 1st year forecast.
- Plan and coordinate the execution of process characterization and validation.
- Successfully complete all process development engineering elements of the PDP by the milestone dates.
- Partner with production to ensure all LMR builds and first 3 months of commercial builds completed on time.
- Create all required documents (manufacturing processes, protocols, reports, etc.).
- Ensure process capability and yield targets are met.
- Provide mentoring and direction to more junior technical staff.
- Hands-on development of manufacturing processes.
- Design, develop, and qualify (IQ) tooling/equipment.
- Develop and qualify in-process test methods (TMV, test method validation).
- Present status of plans and projects to larger team.
- Develop requirements and procure equipment for manufacturing processes.
- Lead small teams for process development or problem-solving.
- Bachelor's degree in an engineering/technical discipline required.
- Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years relevant experience.
- Demonstrated problem-solving leadership skills (A3 DMAIC, first principles, and DOE).
- History of successfully transferring projects to manufacturing.
- Green Belt or Black Belt training/certification; Minitab skills (normality, capability, hypothesis test, DOE, gage R&R, etc.).
- Medical device catheter manufacturing experience.
- Experience with polymer extrusion, reflow, thermal bonding, and adhesive bonding.
- Process error proofing (poka-yoke) experience.
- Fixture design and development.
- Experience meeting time-bound objectives.
- Demonstrated project planning and execution.
- Good presentation skills.
- Leadership and self-starter qualities.
- Experience developing and validating medical device manufacturing processes (IQ, OQ, PQ, and PPQ).
- Working knowledge of PFMECAs, sampling plans, normality assessment, and capability assessment.
- Process validation protocol and report writing.
- Class II or III medical device manufacturing experience.
