Senior Research and Development Engineer
-/+ 1 yr
BHI Energy is searching for a Senior R&D Engineer on behalf of one of our clients. This is a great opportunity to work for one of the world's leading medical technology suppliers and customer-focused solutions provider. If you want to join this company, apply now for consideration.
This is a Direct Hire position located in Reno, NV.
The Senior R&D Engineer will be part of the Product Development team, owning R&D programs from conception through transfer to manufacturing. This individual will define product requirements, develop, and refine designs in CAD and determine and execute required testing, as well as manage the timeline for the program's internal and external cross-functional activities.
- Capture user inputs, create concepts & prototypes, define outputs, perform design analysis, documentation verification, validation, and useability testing customary in the design and development of medical devices.
- Manage design control activities. Draft phase review documents. Lead phase review meetings. Adhere to QMS.
- Perform engineering evaluations /testing necessary to ensure necessary device performance.
- Interface effectively with internal and external teams (i.e., suppliers, consultants, service providers, contract manufacturers, test labs, customers, sales reps, physicians, etc.)
- Investigate, troubleshoot, and resolve device, subassembly and component issues.
- Develop detailed, realistic overall program schedules and adhere to them, driving the other functional areas required for program success.
- Manage engineering intern and/or junior engineer.
- Experience designing and developing ophthalmic surgical equipment (preferred) or medical devices that are subject to design control and regulatory requirements.
- Familiarity with the variety of materials and manufacturing processes common to disposable medical devices.
- Appreciate the value of and have experience utilizing risk management techniques and statistical analysis.
Education and Experience
- Education: BS degree in Mechanical Engineering, biomed engineering, or equivalent work experience.
- Experience: 5+ years, with recent experience within medical device industry.
- Scope of Expertise: led at least one disposable med device program through design, development, FDA clearance and commercialization.
- Plastics: strong background in designing injection-molded components and mechanisms that utilize them.
- Fixturing: experienced in the design and use of manufacturing equipment/fixtures/tooling and IQ, OQ, PQ.
- IP: Experienced in reading and understanding patents and drafting claims.
- Standards: GMP, GDP, 21 CFR 820, ISO 13485 / 10993, IEC 80601 / 60601, and ISO 9000 familiarity.