R&D and product development leader, Advanced Wound Care and Combination Product Development
Send a job offer directly to this candidate
Medical Device and Biomaterials professional with 17+ years of experience in regenerative medicine, advanced wound care, biomaterials, hydrogels, combination products, design controls, risk management, and commercialization.
Led R&D and product development of biomaterials, hydrogels, regenerative medicine, wound care, and medical device products from concept through commercialization.
Directed cross-functional teams across R&D, Quality, Regulatory, Manufacturing, Clinical, and Marketing functions.
Managed new product development (NPD) activities including feasibility, design controls, verification, validation, risk management, and technology transfer.
Developed and optimized advanced biomaterials, tissue-engineered products, drug delivery systems, and combination products.
Oversaw FDA-regulated product development, ensuring compliance with design controls, ISO 13485, ISO 14971, and ISO 10993 requirements.
Led manufacturing scale-up, process development, pilot production, and commercialization activities.
Managed external CROs, CDMOs, testing laboratories, suppliers, and strategic partners.
Conducted biocompatibility, preclinical testing, product characterization, and performance evaluations.
Supported regulatory submissions, technical documentation, risk assessments, and quality system compliance.
Drove innovation, intellectual property development, patent generation, and technology platform advancement.
Collaborated with clinical, scientific, and commercial stakeholders to translate research into market-ready products.
Provided technical leadership for advanced wound care, regenerative medicine, soft tissue repair, and medical device development programs.
Oregon State University, Corvallis, OR,
University of Rochester, Rochester, NY,
