onsite
Director of Engineering - Osteal Therapeutics
Engineering Manager
Lead engineering for a breakthrough orthopedic infection therapy, driving product development, regulatory strategy, and cross‑functional execution to bring a first‑of‑its‑kind FDA Breakthrough Therapy to market.
About the role
Key Responsibilities
- Lead and mentor a multidisciplinary engineering team to design, develop, and scale the NEXCHANGE™ KIT platform.
- Collaborate with R&D, clinical, and regulatory teams to ensure product design meets FDA Breakthrough Therapy requirements.
- Drive project timelines, budgets, and resource allocation, ensuring on‑time delivery of milestones.
- Implement robust quality systems and documentation to support GMP manufacturing and clinical trials.
- Champion continuous improvement initiatives, leveraging data analytics to optimize product performance and manufacturing efficiency.
Requirements
- 10+ years of engineering leadership in a biotech or medical device environment.
- Deep understanding of FDA regulatory pathways, especially Breakthrough Therapy designation.
- Proven track record of delivering complex, high‑impact products from concept to commercialization.
- Strong project management skills with experience managing cross‑functional teams.
- Excellent communication and stakeholder management abilities.