Position: Staff R&D Engineer

Location: Reno, NV

Summary

Have you ever wanted to work at a medical device company and help people have a better quality of life? You can help people see clearly again! We make game-changing surgical devices for cataract surgery, the most-frequently performed surgery in the world. Our handheld devices enable the next generation of cataract surgery, often resulting in quicker patient recovery in addition to other benefits for doctors and surgery centers.

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. The ideal candidate will define product requirements, develop and refine designs in CAD, determine and execute tests for required product parts, assemble 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.

· Excel in the development of system/mechanism architecture for novel medical devices and skilled in troubleshooting design and performance issues that arise.

· Ensure design control is adhered to; draft design history file documents and lead stage-gate phase review meetings.

· Must be able to produce and stick to reasonable development timelines, in a self-motivated, self-directed fashion with little oversight.

· Perform engineering evaluation and testing necessary to ensure the robustness and proper performance of products.

· Interface professionally and 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

· 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.

Qualifications:

· BS degree in Mechanical Engineering or equivalent

· 7+ years engineering experience. Disposable medical device experience required.

· Engineering level math.

· Equipment and tooling design.

· Interpersonal and collaborative work style. Strong written and verbal communication skills and exceptional design problem solving skills

· PC skills: MS Office and SolidWorks are a “must”

· Materials and processing knowledge. Experienced in reading and understanding patents. GMP and ISO13485 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, appropriately capturing the design intent 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 or wet lab bench 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 (2-3 international trips, 3-4 domestic trips approx. per year).

· Ability to interact with physicians confidently and credibly.

· Self-driven and able to lead and manage others effectively.

· Prior startup environment work experience strongly preferred. This person will need to be willing and able to help as needed meeting key deadlines.

· Clean room experience required.

· 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.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Medical Device Engineering: 7 years (Preferred)

Willingness to travel:

• 25% (Preferred)

Work Location: One location

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