Senior R & D Engineer-Medical Device

Moximed; Fremont (CA); On-site; USD 155,000 - 185,000; Full time

Benefits offered by this job

Health insurance

Disability Insurance

401K

Paid time off

Holidays

Flexible work schedules

Job summary

Moximed, a private medical device company based in Fremont, CA, is seeking a Senior R&D Engineer to contribute to the MISHA Knee System. You will design and validate surgical tools, work with cross-functional teams, and translate design inputs into compliant product improvements.

The role emphasizes hands-on CAD work, validation testing, and collaboration with surgeons. A strong background in mechanical engineering and medical device development is required.

Qualifications

• Bachelor’s degree in mechanical engineering or equivalent.
• 6–12 years of medical device product development experience.
• Excellent SolidWorks knowledge and CAD practices.
• Understanding of manufacturing technologies (machining, molding, extrusion).
• Experience with tolerance stack-up analyses and ISO 14971 hazard analysis desirable.

Responsibilities

• Lead and participate on multidisciplinary project teams for design and development of surgical tools.
• Generate ideas, create prototypes, and document disclosures.
• Collaborate with physicians and stakeholders to identify unmet needs.
• Develop tests, procedures, equipment specs, protocols, and reports.
• Design mechanical components of hand-held instruments for MISHA knee system.
• Perform hands-on bench testing and cadaver work to guide decisions.
• Communicate design choices via presentations and documentation.
• Work in lean R&D group and collaborate across functions to hit milestones.
• Suggest and drive improvements to R&D, design control, and change control.
• Travel up to 20% to visit suppliers/end-users.
• Other duties as needed.

Skills

Mechanical design expertise

Problem solving

Cross-functional collaboration

Education

Bachelor’s Degree in mechanical engineering or equivalent discipline

Tools

SolidWorks

Job description

Moximed is a privately held medical device company based in Fremont, CA. Our dedicated team is engaged in the development, manufacture, and marketing of a unique, patient centric, surgical treatment for knee osteoarthritis (the MISHA Knee System), the first of its kind implantable shock absorber(ISA) for patientswith medial knee osteoarthritis (OA).

We have created a culture that reflects our responsibility to our patients and the opportunity for our team to thrive. With a unique culture of entrepreneurship, enthusiasm, and resilience we organize around goal focused teamwork and transparent accountability to achieve our successes.

We are currently seeking a dynamic Senior R&D Engineer to join our growing organization

YOUR PURPOSE

The Engineer will work within a regulated quality system environment to design product for the Company's 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 pipeline development, product improvements and verifying/validating changes against design inputs and intended use. Must enjoy the team approach over individual contributions.

YOUR RESPONSIBILITIES

• Lead and participate as a member of multidisciplinary project teams responsible for the design and development of surgical tools.
• Generate new ideas, create prototypes, solve problems, and complete idea disclosures to advance the Company's procedures.
• Work with physicians and other key stakeholders to understand and identify unmet needs.
• Develop and document test methods, procedures, equipment specifications, protocols, and reports to support on market and development projects
• Design and define mechanical components of hand-held surgical instruments for a minimally invasive surgical technique.
• Hands-on work with cadavers and bench testing to make data-driven decisions to support product development.
• Communicate design choices and reasons for both verbally and through presentations.
• Work within a lean, focused R&D group and manage/collaborate with cross-functional team members to achieve milestones.
• Suggest, contribute, and champion initiatives to improve R&D, design control, and change control practices.
• May require up to 20% travel to visit suppliers, end-users, etc.
• Other responsibilities may be assigned to meet the needs of Moximed.

OUR REQUIREMENTS

Education and Training

• Bachelor’s Degree in mechanical engineering or equivalent discipline preferred.
• 6-12 years of medical device product development experience is required. Preference is given to orthopaedic medical device development.
• Excellent SolidWorks knowledge, good CAD practices, and skills for the creation and revision of parametric models and ASME Y14.5 compliant engineering drawings.
• Understanding of common manufacturing technologies (machining, molding, extrusion, etc.)
• Ability to interpret and perform tolerance stack-up analyses.
• Knowledge of descriptive statistics and sampling methodology is required at minimum.
• Exposure to dFMEA to inform ISO 14971 hazard analysis is desirable.

Technical

• Excellent problem solving, strategic thinking, decision making, analytical, and oral / written communication skills required.
• Results oriented, strong sense of ownership, and committed to achieving meaningful results.
• Ability to work well under pressure to meet deadlines in a cross-functional team environment.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.Ability to work independently with minimal supervision daily.
• Strong mechanical design, CAD modeling skills, and ability to support and communicate design choices are instrumental in this role.

GOOD TO KNOW

• Requires being in office Monday through Wednesday subject to change depending on business and/or department needs

WHAT WE OFFER

Moximed offers a comprehensive benefits package including competitive pay, health insurance, Disability Insurance, pre and post tax 401K, paid time off plus holidays, and a flexible approach to work schedules. Compensation range for this full-time role is $155,000 - $185,000. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors. Total compensation may also include additional forms of incentives.

At Moximed we believe that the unique contributions of all our team members create our success. To ensure that our culture continues to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, marital, veteran, or disability status