BHI Energy is searching for a Staff 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.

Summary

The Staff R&D Engineer, reporting to the Sr. Director of R&D, will manage New Product Development & Introduction, executing R&D projects from conception through transfer to manufacturing. This person will define product requirements, develop and refine designs in CAD and determine and execute tests required. The Staff R&D Engineer will produce part & assembly drawings and handle patent review & drafting.

Essential Functions

• Capturing user inputs, producing concepts, defining outputs, and executing on design analysis, prototyping, documentation and functional verification and validation common to the development of medical devices.
• Ensure design control is adhered to; draft phase review documents and lead phase 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.

Investigate, troubleshoot, and resolve device, subassembly and component issues.

Manage engineering intern and potentially junior engineer

• Candidate shall have knowledge and experience designing and developing ophthalmic surgical equipment or medical devices subject to design control and FDA regulatory requirements.
• Candidate shall be familiar with the variety of manufacturing processes common to medical device development. This person shall understand the value of and have experience utilizing risk management techniques.

Education/ Experience:

• BS degree in Mechanical Engineering
• 7+ years engineering experience, most of which is within the medical device or other regulated industry. Disposable device experience required.
• Equipment and tooling design experience.
• Interpersonal and collaborative work style. Strong written and verbal communication skills and exceptional design problem solving skills
• PC skills: MS Office Suite and SolidWorks are a 'must'
• Materials and processing knowledge.
• Experienced in reading and understanding patents and ability to draft patent claims.
• GDP, GMP, and ISO 9000 training.
• Ability to identify problems and take corrective measures to solve them quickly and efficiently.
• Experience with phase-gate design review documents including slides for presenting. Must have ability to lead design review meetings, capturing feedback and incorporating to allow the design stage to be closed and signed/approved in a timely fashion.
• Must possess ability to produce engineering drawings with the appropriate views, dimensions & tolerancing, as well as notes for suppliers and rev control.
• Proven experience creating protocols for proper execution of testing.
• Must be 'hands-on' working on the R&D bench and tissue wet lab bench assembling prototypes, testing, experimenting, debugging designs.
• Comfortable working with human cadaveric and animal tissue.
• Experience training and proctoring surgeons, including during operating room procedures and able to properly follow all required OR protocols and represent the company professionally.
• Able to interact with physicians, capably, credibly, confidently and effectively.
• Ability to travel as needed (1-2 potential international trips; up to 3-4 domestic trips per year).
• Self-driven and able to lead and manage others effectively.
• Prior startup environment work experience strongly preferred: willing and able to help as needed to meet key deadlines.
• Clean room experience
• Experienced with sterilization validation, biocompatibility testing, transit testing, accelerated aging, cytotoxicity, packaging, cycle life testing.
• Physical requirements: standing, sitting, walking, stairs, light lifting, manual dexterity, operating computers. Ability to tolerate direct exposure IPA, adhesives, part cleaning solutions and other materials common to medical device production.