The Manufacturing Test Development Engineer plays a key role in implementing best-in-class subsystem test processes for a revolutionary radiation therapy medical device. Major objectives are to develop, qualify, and routinize the manufacturing subsystem tests to support commercial ramp and meet company objectives for quality, delivery, and cost. The successful candidate will demonstrate a solid understanding of complex electrical test equipment, electrical test process and best practice methodologies and in compliance with regulatory requirements.
- Partner with R&D engineers to develop the functional test processes for new products and transfer into routine manufacturing.
- Develop electrical functional tests for subsystem boxes to ensure proper function before integration or shipment to the field.
- Generate detailed test documentation (MPI’s, travelers, BOM’s), and conduct training for test technicians as needed.
- Design/oversee test 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.
- Develop tests to ensure field replacement parts are qualified before shipment and that returned subsystems can be repaired and tested before returning to stock.
- 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 presentations 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 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 using test software or scripts for testing to support manufacturing appropriately. Experience with LabVIEW is preferred
- 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%
Company Benefits and Perks – What you will love about us!
All positions at RefleXion are eligible to receive the same benefits, listed here. We also want to highlight the following perks that add to our collaborative and team-work company culture. As we continue to grow as a company, we strive to have these benefits and perks grow with us – we are so excited for what is in store!
- The opportunity to work with a passionate, driven team in a pre-IPO start-up environment
- Competitive compensation and stock option package
- Three (3) weeks PTO to start
- Medical (both HMO and PPO options), Dental and Vision
- Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
- Employee Assistance Program (EAP)
- Employer paid Life Insurance
- RefleXion Benefit Hub – for company exclusive discounts and deals on a variety of sites and items
- Free daily on-site lunches
- Kitchens filled with a variety of healthy and delicious snacks and drinks – including espresso and soda machines!
- Company culture building events such as Coffee Chats with the Executives, Friday Afternoon Ice Cream Socials and monthly Book Club
- On-site mobile car wash services weekly
- Electric car charging stations on site