Project Engineer, Biologics (MedTech)

Location: Audubon, Pennsylvania, United States; onsite at headquarters. The role requires attending surgeries and/or labs and includes 10–15% travel.

Company

Medical technology company developing products and techniques that improve surgical outcomes and quality of life for patients with musculoskeletal disorders.

What you will do

• Develop biomaterials for orthopedic and other therapeutic applications, including stem cell-based therapies, allograft tissue, synthetic scaffolds, and related biologic products.
• Lead product development from concept and prototyping through testing, manufacturing, FDA approval, product introduction, and post-introduction monitoring.
• Develop protocols and methodologies for in vivo animal studies and prepare accurate reports.
• Perform design verification and validation activities to confirm products meet specifications.
• Gather feedback from spine surgeons and other customers, and research markets and competitors to guide product requirements.
• Manage project plans, Design History Files, regulatory compliance, product introductions, and customer change requests.

Requirements

• Bachelor’s degree in a scientific field and 3 years of relevant experience; a master’s or PhD is preferred.
• Strong documentation skills and the ability to write accurate test procedures, summaries, and reports.
• Excellent written and verbal communication skills, including the ability to explain complex issues clearly and logically.
• Ability to develop innovative solutions to complex problems and collaborate effectively with key stakeholders.
• Ability to attend surgeries and/or laboratories and travel 10–15%.

Culture & Benefits

• Work is centered on innovation, patient care, customer focus, teamwork, and decisive execution.
• Collaboration with researchers, educators, surgeons, healthcare providers, customers, suppliers, and other stakeholders.
• Work must comply with applicable quality systems, regulatory requirements, company policies, and medical technology codes.
• Inclusive equal opportunity workplace with reasonable accommodations available for individuals with disabilities.