Senior Product Development Engineer (Fremont)

Moximed is seeking a Senior Product Development Engineer to join our team. The Senior Engineer will work within our regulated quality system environment to further develop Moximeds joint unloading technology embodied by the MISHA Knee System cleared by the FDA. In this role you will be working with cross-functional groups. Your role will be essential in developing product improvements and verifying / validating changes against intended use, user needs, and product requirements. A a member of our team you must enjoy the team approach over individual contributions. Experience with product development after design transfer to production is required.

Key Responsibilities

• Build on current product and joint unloading technology following design control procedures and principles.
• Work within a lean, focused R&D group and manage / collaborate with cross-functional team members to achieve milestones.
• Analyze and interpret customer feedback, complaints, and retrieved products to drive and support product development activities.
• Collect data to support the business case and design input for development projects. This includes root cause analysis, cost estimates from suppliers, and one-on-one or focus group meetings with end-users including surgeons, nurses, and other healthcare workers. The ability to assist with COGS assessments is desirable.
• Integrate cross-functional groups early in the development and provide consistent updates.
• Create and perform engineering validations and verifications challenge existing tolerances, mechanical testing, packaging testing, etc.
• Perform risk-based assessments as part of development activities. Experience with developing and executing biocompatibility evaluation plans to support product and process changes is highly sought.
• Prepare and present technical and end-of-phase design reviews to cross-functional group members.
• Maintain accurate documentation including test protocols, reports, and engineering assessment to support quality system and regulatory requirements. Incorporation of lean documentation principles required.
• Suggest, contribute, and champion initiatives to improve R&D, design control, and change control practices.
• Hands-on work with cadavers and in an OR setting to inform on the development and refinement of hand-held surgical instruments and minimally invasive surgical techniques.
• May require up to 20% travel to visit suppliers, end-users, etc.

Education and Training

Technical Requirements