The Manufacturing Engineer plays a key role in implementing best-in-class manufacturing assembly and test processes for a revolutionary radiation therapy medical device. Major objectives are to transfer, qualify, and routinize the manufacturing assembly and test processes to support commercial launch and meet company objectives for quality, delivery and cost. The successful candidate will demonstrate a solid understanding of complex electro-mechanical equipment assembly utilizing best practice methodologies and in compliance with regulatory requirements.
- Partner with R&D engineers to develop the assembly and test processes for new products and transfer into routine manufacturing.
- Generate detailed assembly and test manufacturing documentation (MPI’s, travelers, BOM’s), and conduct training for assembly technicians as needed.
- Design/oversee that assembly equipment, fixtures and tools are developed to meet quality, safety and performance objectives.
- Ensure product quality by implementing effective process controls and conduct pFMEA risk assessments.
- Implement Lean manufacturing practices to optimize product quality and manufacturing efficiencies.
- Execute process validation through IQ, OQ, PQ, PPQ and TMV.
- Work closely with materials management, Quality, and vendors to assure that purchased material meets specifications.
- Develop field replacement & test processes for Field Service
- Ensure manufacturing compliance with all Safety and Quality regulations.
- Troubleshoot component/system failures during assembly and as part of corrective action investigations.
- Generate engineering reports, justifications and MTF’s to support ECO’s, NCR’s, complaints and CAPA’s.
- Drive design and process optimization for manufacturability, serviceability and reliability as part of continuous improvement activities.
- BS required in Mechanical, Electrical or similar engineering discipline.Minimum of 5 years direct experience as a Manufacturing/ NPI/R&D engineer in a relevant environment
- 3+ years of experience with complex electromechanical equipment (radiotherapy medical device experience preferred)
- Experience with assembling and trouble-shooting electromechanical assemblies with tight mechanical tolerance
- Experience using test software or scripts for testing to support manufacturing appropriately
- Working knowledge of FDA QSR’s and ISO 13485
- Experience performing pFMEA, IQ, OQ, PQ, PPQ, and TMV
- Lean manufacturing knowledge such as visual factory, poka-yoke, 5S, waste elimination, and kaizen
- Experience with data driven engineering methodologies such as DOE, GRR, SPC and 6 Sigma
- Experience interacting with suppliers to ensure product conformance, cost effectiveness and outsourcing initiatives
- High attention to detail and organizational skills
- Excellent document writing skills
- Strong team player and interpersonal skills
- Willingness to travel up to 10%
- Experience with Ultra High Vacuum systems including the ability to run Helium leak detectors