Senior Director, Research & Development

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

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.

• 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.

• 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.

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

• 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.

• 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 (Solid Works or equivalent) at a level sufficient to review and redline engineering drawings and models.

• 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…