Director of Research & Development

Femasys•Suwanee, GA

About The Position

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.

Requirements

Bachelor’s degree in Engineering or related field.
8–12+ years of medical device development experience.
Strong knowledge of FDA design controls and manufacturing transfer.

Nice To Haves

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

Responsibilities

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