Senior Engineer, R&D: Lead Medical Device Innovation

axogen; Tampa (FL); On-site; USD 92,293 - 115,367; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401k matching

Paid time off

Holidays

Tuition reimbursement

Parental leave

Stock purchase plan

Disability insurance

Job summary

Axogen is seeking a Senior Engineer, R&D to lead the development of innovative products addressing peripheral nerve injuries from concept through commercialization. You will collaborate with Quality, Regulatory, Operations, Marketing and Medical Affairs to ensure alignment and timely execution, using strong technical communication across audiences.

The role requires conducting studies, analyzing data, and providing technical recommendations, while managing multiple projects with attention to

Qualifications

• Strong technical communication skills for diverse audiences.
• Experience in medical device product development and design controls.
• Understanding of regulatory requirements (FDA/ISO) for medical devices.
• Ability to lead projects and collaborate with QA, Regulatory, Operations, and Marketing.

Responsibilities

• Lead development of new medical devices and technologies from concept to commercialization.
• Serve as technical lead for moderate complexity programs.
• Collaborate with QA, Regulatory, Operations, Marketing and Medical Affairs.
• Engage with customers and stakeholders to translate needs into design requirements.
• Generate, prototype, and evaluate designs; optimize through tests and analysis.
• Ensure activities comply with Design Control and quality systems; conduct V&V.

Skills

Technical communication

Cross-functional leadership

Regulatory awareness

Problem solving

Attention to detail

Education

Bachelor's degree in Biomedical/Mechanical/Chemical Engineering or Materials Science

Job description

Axogen is seeking a Senior Engineer, R&D to lead the development of innovative products addressing peripheral nerve injuries from concept through commercialization. You will collaborate with Quality, Regulatory, Operations, Marketing and Medical Affairs to ensure alignment and timely execution, using strong technical communication across audiences.

The role requires conducting studies, analyzing data, and providing technical recommendations, while managing multiple projects with attention to