Principal Engineer, Absorbable Materials and Scaffolds, R&D - MedTech

Principal Engineer, Absorbable Biomaterials and Scaffolds, R&D – Med Tech (Flex/Hybrid; Irving, TX strongly desired or Raritan, NJ; 3 days/week on-site).

Serve as SME and technical lead applying polycaprolactone (PCL)-based biomaterials to develop 3D printed bioabsorbable scaffolds for soft tissue applications (e.g., breast implants).

• Collaborate with an external technology partner on PCL materials for breast implant/soft tissue applications.
• Coordinate with 3rd-party PCL and absorbable material suppliers.
• Lead knowledge transfer on materials, suppliers, specifications, performance, and safety data.
• Conduct/coordinate degradation, absorption, and mechanical performance testing; author technical reports/deliverables into design history files per ISO 13485 and quality protocols.
• Co-lead preclinical performance/safety/absorption testing with cross-functional teams.
• Translate material science into scaffold architecture requirements and product performance parameters.
• Partner cross-functionally (R&D, Clinical, Regulatory, Quality, Manufacturing) for end-to-end production development and design transfer.
• As material SME: advise on performance for transfer/scalability, regulatory submissions/documentation, preclinical study design/data review, claims support (with GSM/Scientific Affairs), and product performance testing; build internal/external capabilities.

• MS or Ph.D. in Absorbable Biomaterials Science, Polymer Science, Chemical Engineering, or related.
• 5+ years relevant medical device industry experience.
• Strongly preferred: absorbable biomaterials for implantable medical devices.
• Strongly desired: PCL properties/degradation kinetics/formulation; 3D printing for scaffold fabrication/characterization.
• Strongly preferred: ISO 13485, ISO 10993, ISO 1460, ISO 14971; design control systems.

• Biofabrication, Biomaterials, Biostatistics, Critical Thinking, Laboratory Experiments, Medical Affairs, Product Development/R&D, Safety-Oriented, Technical Credibility, Technical Writing, Resource Planning, Coaching, Organizing, Healthcare Trends, Global Market, SAP Product Lifecycle Management.

• Vacation 120 hrs/yr
• Sick time 40 hrs/yr (CO 48, WA 56)
• Holiday pay incl. floating holidays 13 days/yr
• Work/Personal/Family Time up to 40 hrs/yr
• Parental Leave 480 hrs/yr (within one year)
• Bereavement Leave 240 hrs immediate/40 hrs extended
• Caregiver Leave 80 hrs (52-week rolling period)
• Volunteer Leave 32 hrs/yr
• Military Spouse Time-Off 80 hrs/yr