RefleXion Medical is on a mission to create a new cancer treatment modality through biological guidance. By leveraging positron emission tomography (PET) in a novel way, RefleXion’s patented technology causes tumors to continuously signal their location during treatment, potentially revolutionizing cancer care.
We’re passionately committed to making dramatic changes to cancer care, and we believe that small, lean teams of brilliant people are the only way to do that. We need teammates with both the foresight and experience to avoid roadblocks, and the drive and creativity to steer around those that inevitably appear. We seek those who will unabashedly and relentlessly help us create a new modality in cancer care.
If you are bold and inventive – we want you.
If you combine passion with experience – we want you.
If you embrace iteration and constant learning – we want you.
Come and join a company on an incredible and meaningful mission.
The NPI Electrical Engineer plays a key role in the development, formal testing and transfer into manufacturing of the 100 kW AC power distribution system and control electronics for a revolutionary radiation therapy medical device. Major objectives are to support design development projects, plan and execute verification and validation testing, perform risk assessments and implement appropriate manufacturing process controls. The successful candidate will demonstrate a solid understanding electrical and electronic design considerations for complex, high-power, permanently installed capital equipment, as well as very effective 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.
Roles and Responsibilities:
- Create detailed project plans for the prototyping, testing and qualifying of electrical and electronic 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, routers) 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.
- Assist manufacturing engineering with the qualification of test methods through GRR’s and attribute test method validations.
- 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, justifications and MTF’s to support CO’s, NCR’s, complaints, and CAPA’s related to product design.
- Assist in troubleshooting electrical and electronic component/system failures during assembly and as part of field service activities.
- Minimum of 5 years direct experience as a NPI/R&D/Manufacturing Engineer in a relevant environment.
- BS required in Electrical Engineering.
- 3+ years of experience with high power capital electrical equipment (radiotherapy medical device experience preferred).
- Experience with assembling and trouble-shooting electrical power distribution and control panels and electronic subsystems.
- Experience with manfacturing equipment listed to IEC 60601, IEC 60950, or IEC 61010, including FUS.
- Familiarity with medical capital equipment, especially radiotherapy machine,s preferred.
- 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, DOE, V&V, and 6 Sigma.
- 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%.