The NPI Engineer plays a key role in the development, formal testing, and transfer into manufacturing of various electro-mechanical subsystems for a revolutionary radiation therapy medical device. Major objectives are to support design development projects, assist in verification and validation testing, perform risk assessments, conduct pFMEAs, develop manufacturing processes and implement appropriate manufacturing process controls. The successful candidate will demonstrate a solid understanding of product development, technically and logistically as well as design transfer of a medical device. They will also possess strong project management and interpersonal skills. This role will serve as the primary engineering liaison between R&D and Manufacturing and will be an evolving position in an exciting start-up company environment.
- Create detailed project plans for the prototyping, testing, and qualifying of complex electro-mechanical components/systems as part of formal Design Control.
- Collaborate with manufacturing engineers to establish the production processes and test methods.
- Generate detailed documentation (drawings, schematics, MPI’s, BOM’s, Mfg routings, etc.) in support of manufacturing and servicing of the product.
- Ensure product performance through d/pFMEA risk assessment and implementation of effective process controls.
- Assist manufacturing engineering with the validation of equipment and processes through IQ, OQ and PQ’s.
- Project management of design development projects with key suppliers.
- Drive design optimization for manufacturability, serviceability and reliability as part of new product development and/or continuous improvement activities.
- Generate engineering reports, change orders, rework instructions, NCRs, related to product design.
- Assist in troubleshooting component/system failures during assembly and as part of prototype creation and support.
- Minimum of 8 years direct experience as an NPI/R&D/Manufacturing Engineer in a relevant environment.
- BS required in Physics, Mechanical Engineering, or similar discipline.
- 3+ years experienced with medical device design control concepts such as design input, design output, traceability, risk analysis, and V&V testing.
- Working knowledge of FDA QSR’s, ISO 13485 and IEC 60601 and collateral standards.
- Demonstrated DFM knowledge including mistake-proofing, simplification, standardization and testing.
- Proven experience with data driven engineering methodology such as FMEA, reliability testing, GRR and DOE.
- Experience with linear accelerator/e-beam technology a plus.
- Familiarity with radiation sensing devices (imaging), a plus.
- Strong attention to detail and organizational skills.
- Excellent project management and interpersonal skills.
- A passion for creating robust and reliable products.
- Willingness to travel up to 10%.