The Manufacturing Engineer plays a key role in implementing best-in-class manufacturing assembly and test processes for the Positron Emission Tomography (PET) detector and control electronics for a revolutionary radiation therapy medical device. Major objectives are to support, improve, and routinize the manufacturing assembly and test processes to support commercial ramp and meet company objectives for quality, delivery and cost. The successful candidate will demonstrate a solid understanding of electrical and electronic manufacturing considerations for complex, high-power, permanently installed capital equipment. This role will be an evolving position in an exciting start-up company environment.
- 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.
- Maintain an Electrostatic Discharge (ESD) program to meet the needs of complex sensor assemblies.
- 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 electrical and electronic 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.
- Other duties as assigned
- BS required in Engineering.
- Minimum of 5 years direct experience as a Manufacturing/ NPI/R&D engineer in a relevant environment
- 3+ years of experience with sensor electrical equipment (radiotherapy medical device experience preferred)
- Experience with assembling and trouble-shooting electrical sensor systems and electromechanical assemblies with tight mechanical tolerance
- Technical expertise with PCA and cable assembly processes
- 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
- Experience with ESD
- 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