Reporting to the VP of R&D, directed Mentor R&D global business with professionals in Irving, Texas; Leiden, Netherlands and Mauritius and with a budget of $5M concentrating on strategic streams of new innovation and product development to meet consumer needs and insights, new technologies, and business opportunity. Translated Business Plan to R&D goals and coordinated shared goals with Marketing, Operations and Shared Services. Partnered with legal groups to protect and develop patent strategies.• Directed cross-functional engineering teams, authored submissions to globally launch 3 FDA Class III and 3 FDA Class II implantable devices by the committed launch date, on budget, one launched 3 months early• Developed innovation strategy based on company goals, multi-phase development plan for synthetic and drug solution to foreign body reactions, viral based cellulose injectable, and collagen/synthetic construct• Presented science-based product evidence to customers at multiple large conferences, education-training events, and in doctor office sales calls• Centralized two European R&D facilities into existing infrastructure to optimize the newly integrated business unit,• Restructured R&D quality systems, improving efficiency for cross-site engineering teams to leverage shared resources and effectively communicate, ensuring on time product market launch• Applied Lean Manufacturing principles to reduce waste through Design for Manufacturability and poke-yoke process• R&D lead for the rapid transfer integration of operations facility into a global supply chains, achieving a lean manufacturing “Pull System” certification for the site, and a culture of Six Sigma 5S+Safety• Planned and executed R&D coverage for a 300% increase in regulatory audit rate and responses for additional device safety data after market removal of competitor device• Co-Leader for Women in R&D Leadership Council within J&J Medical Device and Diagnostics group

Manage Research and Product Development for Class II and III medical devices, biologics, and combination devices.

Achieving market clearance in US and OUS during the first two years of tenor for CPX3 (Medical Device), and R&D review for Neoform (Biologic) and Puragen (Class III combination product). Authored critical documents for third and fourth FDA PMA Module for MemoryShape Breast Implant.

Inspected over 100 FDA regulated companies including manufacturers of medical devices, pharmaceuticals, APIs, and combination products; clinical investigators; and Internal Review Boards. Conducted fifteen (15) PMA and five (5) PAI inspections. Examples of products audited include: Needle and Sutures, silicone implants, implanted neural stimulators, intraocular lenses, blood pumps, IVDs, sterile parental, solid and liquid dosage forms, modified release dosage forms, and drug delivery patches.• Applied quality regulations with technical expertise in cGMPs, QSR, QSIT, GLP, GCP, GAMP, and international standards. • Experienced auditing design and validations for Automated Systems, Injection and Extrusion Molding, Sterile fill and Packaging, Cleaning and Equipment, and laboratory quality systems. GLP and GCP experience in toxicology and all phases of clinical trials. • Reviewed EO, Gamma, Dry Heat, E-beam, and Steam Sterilization validations.