Consultant
Problem-solving medical device and combination product engineer with extensive experience in systems engineering, change control, product development, post-launch support, project management, and leadership. Known for strong attention to detail, process optimization, organizational skills, and effective communication. Adept at managing complex projects and driving successful outcomes in highly regulated environments.
CORE COMPETENCIES
- Systems Engineering
- Requirement Management
- Risk Management
- Design History Files (DHF)
- Change Management
- Project Management
- Technical Writing/Protocols/Reports
- 21 CFR 820/21 CFR Part 4
- ISO 13485/ISO 14971
- Audit Support
- Trackwise
- Leadership Development
- Continuous Improvement
- Six Sigma Process Excellence
SELECTED ACCOMPLISHMENTS
- Leadership and Project Management: Led a team of 10 engineers and contractors through a leadership transition, managing a $3M budget, setting goals, and distributing workloads effectively at Pfizer.
- Funded, hired, and onboarded five contract resources to augment staff after conducting an organizational assessment.
- Managed device portfolio conversion from ISO 594 to ISO 80369, ensuring compliance and smooth transition.
- Conducted over 30 design change impact assessments for combination products across multiple sites.
- Design and Change Control: Spearheaded Design History File (DHF) remediation and led new product development initiatives at Pfizer.
- Led design control activities for new injection molds for combination products, coordinating test activities at internal and external labs.
- Drove combination product change controls to completion, supporting FDA submissions with zero inquiries.
- Chaired the Change Control Board at Baxter Healthcare, increasing change control throughput by 60% and reducing change cycle time by 46%.
- Technical Development and Process Improvement: Managed the Technical Development Program at Baxter Healthcare, launching new and improved training programs to meet business needs.
- Established a comprehensive training curriculum within six months after evaluating learner needs.
- Planned and launched global program chapters in Europe and Asia within a year to meet business demand.
- Led Lean Six Sigma Kaizen events, resulting in significant process improvements, cost savings, and enhanced process repeatability.
- Engineering and Product Support: Served as Principal Engineer for electromechanical renal devices, managing and maintaining change control processes for complex medical devices.
- Led the implementation of a year-long, regulatory-mandated serialization change, coordinating efforts across R&D, manufacturing, supply chain, quality, regulatory, and service functions.
- Optimized resource allocation, leading to savings of over $550,000.
- Managed or owned 20+ changes in Trackwise, ensuring consistent implementation and timely closure.
PROFESSIONAL EXPERIENCE
- Pfizer
- Senior Manager, Device Team Lead (Secondment) – Dec 2022 to Jun 2023
- Principal Engineer, Medical Devices and Combination Products – Aug 2020 to Dec 2022
- Baxter Healthcare Corporation
- Manager, Technical Development Program – May 2016 to Feb 2020
- Principal Engineer, Electromechanical Renal Devices – Jun 2013 to May 2016
- Senior Engineer, Disposable Devices – Jul 2009 to Feb 2020
- Staff Engineer, Technical Development Program – Date range not specified
EDUCATION
Bachelor of Science (BS), Mechanical Engineering, Cum Laude
University of Michigan, Ann Arbor, MI
CERTIFICATION
- Six Sigma Green Belt
- 5S Bronze Certification in Lean Workplace Organization
- GMP Manufacturing Process Improvement Certification
TRAINING
- Trackwise
- Lean Six Sigma Kaizen
- Design History File Remediation
- FDA Submission Support
- Technical Writing and Protocol Development
- Project Management and Leadership
