Moximed is a privately held medical device company based in Fremont, CA. Our dedicated team is engaged in the development, manufacture, sales & marketing of a patient centric, surgical treatment for knee osteoarthritis (the MISHA Knee System), the first of its kind implantable shock absorber (ISA) for patients with 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 Director of Research & Development to join our growing organization

YOUR PURPOSE:

The Senior Director of Research & Development is a pivotal leadership role that will own that execution of the MISHA knee system pipeline from early development through commercial release while building the processes, team, and infrastructure that will support a rapidly expanding R&D organization. Working at the intersection of engineering, regulatory, clinical, and commercial functions, the Sr. Director will serve as a critical cross-functional partner across the business, ensuring that every product decision is made with both scientific rigor and market impact in mind. For a technically strong, execution-oriented leader who wants their work to matter (to surgeons, to patients, and to the trajectory of a growing company), this is that opportunity.

WHAT YOU WILL DO

Pipeline Execution & Product Development

• Own and execute the MISHA knee system product development pipeline, driving programs from early development through design freeze, verification & validation (V&V), and commercial release.
• Lead all design control activities for Class I instrument and Class II implant development in compliance with 21 CFR Part 820 and ISO 13485, ensuring design history files (DHFs) are audit-ready at all stages.
• Define and enforce stage-gate milestones, project timelines, and deliverable accountability across all active R&D programs.
• Partner closely with Regulatory Affairs to ensure all development activities align with FDA 510(k) submission requirements and support timely regulatory clearance.
• Manage design verification and validation planning including mechanical testing, fatigue analysis, wear simulation, and biocompatibility testing per ISO 10993, ASTM, and applicable orthopedic standards.
• Collaborate with Operations and manufacturing partners on design for manufacturability (DFM) to ensure smooth transfer of new designs into production.
• Support risk management activities per ISO 14971, including FMEAs and hazard analyses across the implant and instrument portfolio.

Team Leadership & Organizational Building

• Lead, mentor, and grow a high-output R&D team, with accountability for hiring, performance management, and professional development as the organization scales.
• Foster a team culture of engineering rigor, accountability, and urgency appropriate for a rapidly growing early-stage commercial company.
• Continue scaling R&D processes, workflows, and documentation standards that can support headcount growth without sacrificing quality or compliance.

WHAT YOU NEED:

Education

• Bachelor's degree in engineering or a related technical field.
• Coursework or demonstrated expertise in materials science, biomechanics, or mechanical design is highly valued

Experience

• 15+ years of progressive R&D experience in the medical device industry, with at least 5 years in a leadership role.
• Hands-on experience developing and launching orthopedic implants and/or surgical instruments.
• Demonstrated success owning 510(k) submissions as the primary R&D contributor, including preparation of design control documentation and test reports.
• Proven track record of managing and growing small, high-performing engineering teams in a fast-paced, resource-constrained environment.
• Experience building and managing an R&D budget at the program and department level.

Technical Skills

• Strong command of design controls (21 CFR Part 820 / ISO 13485) and the practical application of DHFs, design reviews, and V&V protocols.
• Proficiency in risk management per ISO 14971 and application of FMEAs in implant and instrument development.
• Experience with DFM principles and managing relationships with contract manufacturers and machining partners.
• Familiarity with CAD environments (SolidWorks or equivalent) at a level sufficient to review and redline engineering drawings and models.

Leadership & Soft Skills

• Highly organized, process-oriented executor who thrives on fast-moving environments.
• Strong communicator who can bridge technical engineering details with commercial and executive stakeholders.
• Entrepreneurial mindset that is comfortable building structure and scaling processes as the organization grows.
• Comfortable operating as both a strategic leader and a hands-on contributor in a small team setting.

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

Pay Transparency

Moximed offers a comprehensive benefits package including competitive pay, health insurance, Disability Insurance, 401K, paid time off plus holidays, and a flexible approach to work schedules. Salary range for this role is $175-$225K annually based on an individual's skills, experience, education, and other job-related factors and may include other types of incentives.