R&D Engineer

We are seeking an R&D Engineer to join a specimen management team supporting in‑vitro fertilization (IVF) products within a regulated medical device environment. This role is focused on new product development and pre‑market design, working closely with cross‑functional teams to bring innovative solutions from concept to validation.

• Lead and support design and development activities for IVF/specimen management devices.
• Apply Design for Six Sigma (DFSS) and Design Control principles throughout the product lifecycle.
• Create and revise 3D models and drawings using Pro/E (Creo), Solid Works, and/or similar CAD tools.
• Generate and maintain DHF documentation (requirements, risk management, verification/validation, design reviews).
• Collaborate with quality, regulatory, manufacturing, and clinical teams to ensure designs meet user needs and compliance requirements.
• Support prototype builds, testing, and root cause investigations for design issues.

• Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline.
• 3+ years of R&D or NPD experience in medical devices (Class II/III preferred).
• Hands-on experience with DFSS, Design Controls, and risk management (ISO 13485 / 21 CFR 820).
• Proficiency in 3D solid modeling (Pro/E/Creo, Solid Works, or equivalent).
• IVF, laboratory, or specimen management product experience is a strong plus.