Adam MacMillan
Taking medical devices and biologics from concept to commercialization
- Role
- Director of Product Development at Vertex Pharmaceuticals
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Adam MacMillan
Hands-on medical device engineer passionate about design and development of biomaterials, minimally manipulated tissue products, and medical devices. Proven ability to translate customer needs into successful products while managing project risks, development constraints, and multiple regulatory landscapes. Passionate about using Six Sigma methodologies to improve and lean the product development cycle. Areas of expertise include: Experience Includes-Orthobiologic medical device research, development, and design-Biomaterials process and product development-Preclincal and clinical evaluation of synthetic and tissue based medical devices and implants-Microstructured, nanostructured, and composite bioceramics and bioglasses-Tissue based implantable product design-Medical device instrument design-Spine biomechanical testing-Regulatory strategies for novel technologies including 510(k), CE Mark, and TGA approval-Implantable polymer materials and devices-Sterile packaging -Quality Management; CFR 21 Part 820, ISO 13485, ISO 14971, and MDD 93/42/EECSpecialties: Use of six sigma methodologies (DMDAV, DMAIC) for product design and process control.and I moonlight as a ceramic artist with a focus on macro-crystalline glaze chemistry.
Experience
Director of Product Development
Jan 2026 — Present · Boston, MA, US
Education
Northeastern University
BS, Mechanical Engineering
1999 — 2004
Skills
- Biomaterials
- Iso 14971
- Orthopedic
- Orthopedics
- Fda
- Design Control
- Biologics
- Nanomaterials
- Verification and Validation (V&V)
- Class Ii
- Biotechnology
- Mechanical Testing
- Research and Development (R&D)
- Design for Manufacturing
- Minimally Invasive Procedures
- Product Design
- Six Sigma
- Product Launch
- Minitab
- Surgical Instruments
- Osteobiologics
- Engineering
- Ceramics
- Doe
- Iso 13485
- Spine
- Matlab
- Medical Devices
- Capa
- Ceramic
- U.s. Food and Drug Administration (Fda)
- R&D
- Design of Experiments
- Market Development
- Product Development
- Biomechanics
- Quality System
- V&V
- Commercialization
- Spinal Implants
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