Director of Research & Development

About Femasys Inc.

Femasys Inc. is a leading biomedical company dedicated to advancing womens healthcare through innovative medical solutions. Our mission is to provide safe, effective, and accessible products that improve womens lives worldwide.

Position Summary

The Director of Research & Development is a hands-on technical leader responsible for driving medical device development from early concept through commercialization in a fast-paced, resource-constrained startup environment. This role blends strategic leadership with direct technical execution and requires deep engagement in design, testing, documentation, and manufacturing transfer. The Director will build and lead a small, high-impact R&D team, establish practical yet compliant development processes, and personally contribute to solving complex technical and organizational challenges.

Core Responsibilities

• Hands-On Product Development Actively participate in device design, prototyping, testing, and iteration. Author and review key technical documentation, including design inputs, outputs, verification, and validation protocols, and reports, risk analyses, and change documentation. Lead root cause investigations, design improvements, and issue resolution. Provide technical judgment and decision-making where data may be incomplete or timelines are compressed.

• Design Controls & Quality Execution Own day-to-day execution of design controls in compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971. Ensure design history files are accurate, complete, and inspection-ready. Balance regulatory rigor with startup pragmatism. Partner closely with Quality to ensure alignment and efficient document flow.

• Program & Priority Management Translate business and clinical priorities into actionable development plans. Manage multiple concurrent development efforts with shifting priorities. Make trade-offs between speed, cost, and technical risk.

• Team Leadership & Capability Building Hire, mentor, and develop engineers in a player-coach model. Set clear expectations while remaining directly engaged in execution. Leverage contractors and consultants effectively.

• Manufacturing & Scale-Up Support Lead design transfer activities, including pilot builds and IQ/OQ/PQ support. Work hands-on with Manufacturing and Supply Chain. Support post-launch improvements and issue resolution.

Qualifications

Required:

• Bachelors degree in Engineering or related field.
• 8-12 years of medical device development experience.
• Strong knowledge of FDA design controls and manufacturing transfer.

Preferred:

• Startup or early-stage medical device experience.
• Experience with minimally invasive or catheter-based devices.