Job Title: Product Development Engineer - Spine Implants
Location: Remote with travel as necessary, strong preference for the Mid Atlantic or Memphis, TN
About Foundation Surgical:
Foundation Surgical is an innovative, early-stage spine implant company redefining spine surgery through procedural and implant innovations that preserve motion and improve patient outcomes. Founded by world-renowned spine surgeon Dr. Randal Betz, the company combines deep clinical insight with disciplined product development to challenge long-standing fusion-based approaches.
With recent FDA clearances for the Interwedge® Standalone Lateral Implant System and the Vertiwedge® Intraosseous Device, Foundation Surgical is advancing a differentiated platform in lateral spine surgery while actively developing next-generation posterior technologies. This is a pivotal time to join the company, offering the opportunity to play a meaningful role in shaping multiple product lines and the future of motion-preserving spine care.
Key Responsibilities:
This role is a critical engineering position that provides technical leadership and strategic influence across implant and instrument development. You will guide internal engineering execution, set technical standards, and work closely with our internal team, third-party design partners and contract manufacturers to ensure designs align with Foundation Surgical’ s clinical, quality, and manufacturability objectives in a resource-efficient startup environment.
Product Design & Engineering Execution
- Lead detailed mechanical design of spinal implants and instruments with a strong focus on design for manufacturability (DFM), including titanium additive manufacturing and precision machining.
- Own CAD models, drawings, and specifications using SolidWorks and GD&T, with rigorous attention to tolerance stack-ups and drawing control.
- Serve as the primary technical interface with external design firms, ensuring outputs meet Foundation Surgical’ s design, quality, and manufacturability standards.
Product Development & Design Controls
- Drive engineering execution across new product introduction (NPI) and sustaining programs, from concept through verification, validation, and design transfer.
- Lead creation and maintenance of Design History Files (DHF) in compliance with FDA and ISO 13485 requirements.
- Plan and participate in design reviews, risk management activities (e.g., FMEA), and cross-functional technical decision-making.
Clinical & Training Support
- Act as the primary engineering liaison to surgeon KOLs and clinical partners.
- Provide technical support during cadaver labs, early clinical launches, and selected OR cases.
- Develop and deliver technical training materials for internal teams, distributors, and surgeons.
Regulatory & Quality Support
- Prepare and support technical documentation for FDA Class II (510(k)) submissions.
- Ensure engineering activities comply with the company’s Quality Management System and design control procedures.
Ideal Candidate
- Hands-on builder: Comfortable owning designs end to end and solving problems directly.
- Manufacturing-minded: Designs with machinists and suppliers in mind; DFM is core, not an afterthought.
- Self-directed: Operates effectively with minimal oversight and manages multiple critical-path priorities.
- Growth-oriented: Strong individual contributor today with the potential to grow into a long-term technical leadership role.
Qualifications & Experience
- Education: B.S. or M.S. in Mechanical Engineering, Biomedical Engineering, or a related field.
- Experience: 5 to 10 years of direct, hands-on experience in the orthopedic medical device industry, specifically in Spine Implant Design.
- Product Lifecycle: Proven track record of taking orthopedic implants product from concept through successful FDA clearance and commercial launch.
- Regulatory: Direct experience with FDA Class II (510k) submissions and working within an ISO 13485 certified quality environment.