Roles & Responsibilities :
- 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 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.
Education & Experience :
- Bachelors 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.
- Experience developing and validating medical device manufacturing processes (IQ, OQ, PQ, and PPQ).
- Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.Strong organizational skills, detail oriented.
- Experience with Microsoft Office including Microsoft Word, Excel, and PowerPoint.
- Experience with 3D CAD Software SolidWorks.
- Experience working with Engineering change management software & releasing engineering change orders.
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