***Seasoned Project Manager***

Accomplished leader with 15 years of experience in medical device, diagnostic, & pharmaceutical project management. Expertise in the full project life cycle, cross-functional team leadership, & effective stakeholder communication. Proven track record in fostering long-term relationships with internal & external partners.

Core Competencies

• Extensive Project Management experience in

FDA-regulated industries

• US FDA 21 CFR 820 (QSR/cGMP),

EU IVDR/MDR, CMDR

• ISO-3485, -10993, -14971, IEC60601

• Advanced Technical Writing • Proficient with MS Project, Smartsheet,

MS Office & Google Suite

• Excellent Presenter (written/verbal)

• Team Building & Leadership; Mentoring & Training

• Extensive Cross-Cultural Experience

• Detail-Oriented with “Big Picture” Perspective

Career Highlights

• Led ground-up design & testing of an injection-molded electromechanical cardiovascular medical device for St. Jude Medical (Abbott Labs). Delivered a fully-functioning prototype within 9 months, exceeding test requirements, securing additional funding.

• Served as Technical Project Manager for a Class II xenograft dental implant, achieving comparable performance to competitors at a lower manufacturing cost & customer price.

• Managed inter-division Product Development teams, successfully launching new products & expanding the company's portfolio, generating over $2.5M in additional revenue.

Professional Experience

Roche Diagnostic Solutions (Pleasanton, CA) - Sr Project Manager – February 2021 – Present

• As Global Project Manager IV below plus additional responsibilities:

o EMC/Safety & CSA testing for Class A diagnostic devices to obtain ISO-61010 certification.

o Oversight for market release for products transitioning to EU IVD Regulations.

o Design Change management.

o Collaboration with CLIA lab on a software update project.

o Point-of-contact & negotiator for external OEM; curation of documentation for IVDR Technical Documents.

Roche Sequencing Solutions (Santa Clara, CA) - Global Project Manager IV – May 2020 – February 2021

• Led global cross-functional project team for Class C EU IVDD to IVDR conversions.

• Non-Invasive Prenatal Testing (NIPT) & oncology diagnostic products (reagents kits, hardware & software).

• Managed schedule & budget forecasting with adjustments when required.

• Oversaw ISO-14971:2019 risk management.

• Team motivation at individual & project levels to achieve target milestones.

• R&D projects via Roche product development process; prioritization & development of on-market products to enhance utility, convenience, customer value.

• Co-led rapid deployment "task force" to address challenges observed for on-market products & exploit opportunities.

• Product category Lifecycle Team coordinator & PMO Hub Lead.

• Co-authored "PMO Handbook" reference guide; rapid training & mentoring of new & junior PMs for earlier project starts.

August 2018 – February 2020 Sr Project Manager – Kairos Power (Alameda, CA)

• Led 8 x engineering project teams to design, build & test prototype components for clean & safe high-temperature molten salt small modular nuclear reactor; team comprised senior engineering, finance, accounting, business development, regulatory affairs/licensing & subject matter expert consultants.

• Managed work-stream & overall integrated master-level schedules w/ scenario analysis.

• Action items, meeting notes, & objective feedback on documentation.

• Collaborated with cross-functional team on government awards & contracts from the US Department of Energy.

April 2015 – July 2018 Project Management Consultant – Integrated Project Management (San Francisco, CA)

• Product development & business process leadership for cross-functional teams of up to 30 members.

• Led projects at Abbott Diabetes Care, BioMarin, Arena Pharmaceuticals, & CytomX Pharmaceuticals.

• Managed product requirements, schedules, vendors, manufacturers, pre-clinical & Phase 1/2 clinical study reporting directly to company leadership, with international stakeholder management.

• Proven skills in risk management & negotiation, driving process improvement initiatives.

• Contributed to multiple Centers of Excellence & mentored less-experienced PMs.

April 2014 – March 2015 Design Project Manager - RBC Medical Innovations (Lenexa, KS)

• Led cross-functional team in developing a US Class II electromechanical cardiovascular medical device from initiation to advanced prototype.

• Managed project charter, schedule, budget, & forecasts for labor & materials.

• Conducted meetings with clients & suppliers, providing regular updates through dashboards.

• Prepared SoWs, Additional Project Proposals, & Work Authorizations with contingency planning.

2011–2013 Sr Project Manager - AMD Lasers, Inc. (Indianapolis, IN)

• Managed US FDA Class II dental laser device documentation.

• Developed & conducted training on Corporate & Divisional Quality procedures.

• Served as Technical Advisor during Corporate acquisition by DENTSPLY International.

• Ensured product quality for line expansion with Chinese development partner & manufacturing center.

2007–2014 Sr Project Manager / Sr Scientist - DENTSPLY Tulsa Dental Specialties (Tulsa, OK)

• Led stage-gated Product Development for bone grafting, guided tissue regeneration, & endodontic cleaning products.

• Managed cross-functional teams from concept to launch, collaborating with global divisions & academic associates.

• Supported regulatory submissions & successful product launches in international markets (EU, Canada, Australia).

• Acted as a liaison with vendors, customers, & distributors, ensuring compliance through audits.

• Served as a scientific SME for the cross-divisional Materials Review Board.

• Led CAPA remediation efforts to improve R&D department's efficiency.

• Revised divisional Design Control-based Product Development & ISO-14971-compliant Risk Management Procedures.

• Developed growth strategies for guided tissue regeneration business, resulting in $500K additional revenue & award nomination.

• Managed division's Technical Files, Design Dossiers, & created MEDDEV 2.7.1-compliant Clinical Literature Reviews, Protocols, & Reports.

• Provided mentorship & career coaching to coworkers & less-experienced staff.

2007 Medical Quality Systems Engineer / Chemist - DENTSPLY Friadent CeraMed (Lakewood, CO)

• IQs, OQs, & PQs for FDA Class II & Class III bioceramic medical devices.

• Collaborated on validation protocols & test methods within FDA guidelines as part of the validation committee.

• Curated technical documentation for validation protocols based on historic DHFs.

• Recommended process & SOP optimizations & implementations; designed R&D projects & tests.

2000-2006 Development Scientist - Displaytech, Inc. (Longmont, CO)

• Formulated 1000+ liquid-crystal blends for high-performance digital micro-displays.

• Tested quality & performance using Differential Scanning Calorimetry, optical microscopy, & electro-optic switching.

• Ensured QC for production formulations & presented findings in cross-functional meetings.

• Developed manuals, procedures, SOPs, & technical documents.

• Reviewed for an international scientific journal & conducted research on the displays industry.

• Mentored scientists & technicians.

1998-2000 EU Research Fellow - Technical University of Berlin (Berlin, Germany)

• Designed & led research projects with physicists, chemists, & engineers across Europe; co-authored publications & presented at international conferences.

• Initiated research on new materials; formulated & tested 70+ novel liquid crystal blends; physical & electro-optic measurements, data analysis; conclusions based on evidence & multi-disciplinary theories.

Internship

2006 R&D / Business Development Intern - Wadsworth Control Systems (Arvada, CO)

• Extensive research on environmental control technology, analyzing domestic & international customers, competitors, & alternative markets, along with marketing strategies & emerging online resources.

• Delivered pivotal findings to R&D & Marketing teams.

Education

• Diploma, Clinical Research Associate (ICH – GCP), KRC International, USA, 2014

• MBA, International Business, Regis University, USA, 2006

• PhD, Chemistry, University of Hull, UK, 2000

• MSc, Chemistry, University of Wales, UK, 1995

• BSc, Chemistry (Hons, with minor in Biology), University of Wales, UK, 1993

Publications / Presentations / Patent

• 26 articles in international peer-reviewed journals; 12 presentations at international conferences; 1 Technical White Paper.

• 1 US/EU patent application (co-author, #US 200******** / #WO 200-***-****).

Additional Information

• Mentored 3 external associates without formal PM experience, guiding them to become successful professional PMs in IT, biotechnology, & pharma.

• Former mentee now heads the San Francisco chapter of Project Management Institute.

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