Senior R&D Mechanical Engineer II – Medical Devices

envista; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Envista in Pomona, CA is seeking a Senior R&D Mechanical Engineer II to translate unmet customer needs into commercially viable medical devices. This role combines innovation with hands-on engineering and requires onsite presence four days per week, working with cross-functional teams across R&D, Manufacturing, Quality, Regulatory, Marketing, and Supply Chain.

You will lead design and development of next generation orthodontic products, serve as SME for fixed appliances or aligners, drive

Qualifications

• Bachelor's degree in Mechanical Engineering from a credited university.
• 7+ years of progressive mechanical engineering and product development experience, preferably within medical devices.
• Hands-on mechanical design experience including concept generation, mechanism design, tolerances, DFM/DFA.
• Generate novel product concepts and translate ideas into prototypes and development programs.
• Scientific literature evaluation, GLP understanding, and strong communication.

Responsibilities

• Develop next generation orthodontic products from concepts to prototypes.
• Lead or support multiple product development projects beyond SME.
• Participate in design reviews and verify/validate designs.
• Develop test protocols, reports and risk assessments.
• Collaborate with cross-functional engineers and manufacturing for transitions to production.
• Advise manufacturing, QA and procurement on materials and processes.
• Ensure IQ, OQ, and PQ compliant equipment before production release.
• Travel up to 10%.

Skills

CAD

Statistical methods

Communication

Prototyping

Design reviews

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

MS Office Suite

Job description

Envista in Pomona, CA is seeking a Senior R&D Mechanical Engineer II to translate unmet customer needs into commercially viable medical devices. This role combines innovation with hands-on engineering and requires onsite presence four days per week, working with cross-functional teams across R&D, Manufacturing, Quality, Regulatory, Marketing, and Supply Chain.

You will lead design and development of next generation orthodontic products, serve as SME for fixed appliances or aligners, drive