Biomedical Product Development Engineer; Medical Devices

We are an innovative regenerative medicine company developing next‑generation Class II and III biomedical devices. We are seeking a highly adaptable and motivated Biomedical Product Development Engineer to join our R&D team. In this role, you will be integral to the entire product lifecycle—from early‑stage biomaterial formulation and prototype development to late‑stage testing and regulatory submission. Working closely with senior scientists and cross‑functional teams, you will help generate the critical data required to bring life‑changing regenerative medicine products to market.

• Support the design, formulation, and continuous improvement of biomaterials, scaffolds, and tissue‑engineered prototypes.
• Participate in the development of a new family of antimicrobial devices.
• Execute a variety of analytical, chemical, and mechanical testing assays to evaluate prototype safety, stability, and performance.
• Assist in the optimization of biomaterial processing, handling, and sterilization techniques.

• Draft formal study protocols, execute complex laboratory experiments, and synthesize experimental data.
• Author clear and comprehensive summary reports to document findings for internal review and quality records.

• Assist in the preparation and compilation of technical data and documentation to support regulatory filings for new product indications (e.g., FDA PMA, IDE, or 510(k) submissions).
• Ensure all R&D activities strictly align with our Quality Management System, including FDA 21 CFR Part 820 and ISO 13485 requirements.
• Collaborate cross‑functionally with Quality, Manufacturing, and Regulatory teams to support technology transfer and scale‑up activities.

• Education: Bachelor’s or Master’s degree in Bioengineering, Biomedical Engineering, Materials Science, Chemical Engineering, or a closely related scientific discipline.
• Experience: 5+ years of relevant hands‑on industry experience and product development under design controls. Research experience specifically focused on biomaterials, tissue engineering, or medical devices is highly preferred. Experience with antimicrobial or other drug combination products is highly desired.
• Technical
  
  Skills:
  
  Proven experience with the handling, processing, or characterization of biomaterials and hydrogels. Familiarity with aseptic technique and sterile processing, and preclinical testing is a strong plus.
• Mindset: A demonstrated passion for regenerative medicine and the desire to build a career in medical device product development.

• Adaptability: Highly versatile and comfortable navigating the shifting priorities and dynamic environment of an innovative biotech company.
• Attention to Detail: Meticulous organizational and documentation skills, understanding the critical nature of traceability in a regulated medical device development environment.
• Collaboration: A proactive team player who communicates clearly and is eager to learn.
• Agile Execution: Capable of maintaining high standards of quality while working with a sense of urgency to meet tight project timelines in a fast‑paced, dynamic environment.

We are an equal‑opportunity employer and encourage candidates of all backgrounds to apply. Candidates must be legally authorized to work in the United States without requiring future visa sponsorship (e.g., H‑1B, F‑1 OPT, etc.) at the time of hire or at any point in the future.

This role does not offer sponsorship for work authorization.