Research and Development Engineer
-/+ 1 yr
BHI Energy is searching for a 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.
This is a Direct Hire position located in Reno, NV.
The R&D Engineer, reporting to the Sr. Director of R&D, will assist and lead new product development activities from conception through design, development, testing, and transfer to manufacturing. This person will support product requirements definitions, develop and refine designs in SolidWorks and determine and execute tests required. The R&D Engineer will produce part & assembly drawings as well as patent review & drafting.
- Assist in capturing user inputs, producing concepts, defining outputs, and performing design analysis, prototyping, documentation and functional verification and validation common to the development of medical devices.
- Learn design control requirements and ensure they are adhered to, draft phase review documents and support review meetings.
- Perform engineering evaluation and testing necessary to ensure the robustness and proper performance of products.
- Interface effectively with internal and external teams (i.e. suppliers, consultants, service providers, contract manufacturers, test labs, etc.) to ensure the successful development of new products.
- Participate with other engineers in investigating, troubleshooting and resolving device, subassembly and component issues.
- Have a basic working knowledge of and experience in designing and developing medical devices subject to design control and FDA regulatory requirements.
- Have some familiarity with the variety of manufacturing processes common to medical device development and understand the value of and have some exposure to utilizing risk management techniques.
Education and Experience
- BS degree in Mechanical Engineering or biomedical engineering
- 2+ years engineering experience, preferably within the medical device or other regulated industry. Disposable device experience preferred.
- Exposure to equipment design and tooling design
- Interpersonal and collaborative work style. Strong written and verbal communication skills
- PC Skills: MS Office and SolidWorks are a 'must'
- Materials and processing knowledge.
- Familiarity with patents.
- GDP and ISO 9000 training.
- Ability to identify problems and take corrective action to solve them quickly and efficiently.
- Basic understanding of phase-gate design reviews and the distinction between verification and
- Able to produce engineering drawings with the appropriate views, dimensions & tolerancing, as
- well as notes for suppliers and rev control.
- Ability to draft and properly execute engineering test protocols.
- Must be 'hands-on' in terms of a willingness and interest inworking on the R&D bench or wet lab assembling prototypes, testing, experimenting, debugging designs.
- Comfortable with tissue lab work, and operating room visits - able to follow all protocols.
- Ability to travel as needed (1-2 trips approx. per year).
- Ability to interact with physicians confidently and effectively.
- Prior startup environment work experience preferred. Willing and able to work hard and (at times) long hours if needed to meet important company deadlines.
- Clean room experience is preferred.
- Exposure to sterilization validation, biocompatibility testing, transit testing, accelerated aging, cytotoxicity, packaging, cycle life testing is preferred.