The Senior NPI Engineer provides engineering leadership and support in the development and commercialization of a complex electromechanical, radiation therapy medical device. Major objectives are to establish a production processes and complete Design Transfer of the initial commercial product. Then sustain that product through feature upgrades, cost reductions and other related improvement projects. The successful engineer will demonstrate technical competence in project management, systems engineering and process development, as well as very effective interpersonal skills. This role will serve as the primary engineering liaison between R&D and Manufacturing.
- Primary owner of manufacturing builds during product development, including hands-on assembly
- Collaborate with design engineers to establish the production process ensuring all requirements are met for safety and performance.
- Generate detailed documentation (drawings, schematics, MPIs, Travelers, BOMs, Routings) in support of manufacturing assembly.
- Ensure product quality through pFMEA risk assessment and implementation of effective process controls.
- Execute process qualifications through IQ, OQ and PQ’s.
- Work closely with materials management, Incoming Inspection, and vendors to assure that purchased material meets specifications in preparation for Design Transfer.
- Troubleshoot machine failures at system and subsystem level, during prototype assembly and as part of pilots build leading up to Design Transfer.
- Ensure manufacturing process compliance and support V&V testing for FDA 510(k) submission and clearance.
- Other duties as assigned
- BS required in Electrical, Physics or similar engineering discipline.
- Minimum of 7 years direct experience as a Manufacturing/NPI/R&D Engineer in a relevant environment.
- Demonstrated strong DFM knowledge including mistake-proofing, simplification, standardization, and testing.
- Experienced with data driven engineering methodology such as FMEA, reliability testing, GRR, DOE, V&V.
- Working knowledge of and practical experience with FDA QSRs, ISO 13485 and IEC 60601 and collateral standards.
- Ability to be a proactive and collaborative leader in a dynamic start-up environment.
- Ability to provide guidance and leadership to lower lever engineers.
- Able to run small to medium projects from initiation to production launch.
- Capital equipment Medical Device development and/or manufacturing desired.
- Experience with imaging or radio therapy systems (CT, MRI, PET, SPECT, Medical Linacs) very desirable.
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
- 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