Sr. Process Development Engineer - Katalyst Healthcares & Life Sciences
Bay Area, CA 94146
About the Job
Responsibilities:
- You will participate in or lead Equipment and Process Development, Process Characterization and Process Qualification to support new product introduction.
- You will utilize functional excellence in process development including DFM, process characterization, equipment development, Lean and Six Sigma methodologies.
- You will 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 1 st year forecast
- Plan and coordinate the execution of process characterization and validation
- Successfully complete all the 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 team(s) 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.
Source : Katalyst Healthcares & Life Sciences
