Dwan Marshall
Dallas–Fort Worth,TX
Summary
Strategic Senior Product Manager with a strong engineering foundation and 10+ years leading complex initiatives across medical devices, robotics-assisted surgery, pharmaceuticals, and global manufacturing. Expert in translating technical, regulatory, and operational requirements into scalable product solutions that improve safety, compliance, and user experience. Adept at driving cross-functional alignment across R&D, Quality, Regulatory, Operations, and Supplier Engineering teams. Recognized for leading global QMS integrations, technology transfers, validation programs, and high-risk corrective actions while enabling data-driven decision-making. Skilled in managing product lifecycles, defining requirements, optimizing processes, and delivering products that meet stringent global standards.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Staff Quality Systems Engineer (Technical Management)
Intuitive Surgical
01.2020 - Current
- Lead product-impacting quality and engineering initiatives for robotic-assisted surgical systems, serving as a technical SME across global operations.
- Partner with R&D, Clinical, and Operations teams to translate field observations and user feedback into product requirements, risk mitigations, and design improvements.
- Drive global QMS integration supporting product scalability across the US, EU, Japan, Taiwan, China, India, Canada, and Brazil.
- Lead change control strategy and lifecycle management for product-related processes, ensuring alignment with engineering, regulatory, and manufacturing needs.
- Define and implement quality frameworks (quality plans, SLAs, validation strategies) that support product readiness and market expansion.
- Manage supplier qualification and SCAR programs to ensure component reliability and manufacturing continuity.
- Lead high-risk CAPA initiatives tied to product performance, regulatory observations, and field safety.
- Support global audits and inspections by preparing SMEs, managing evidence, and shaping response strategies.
- Tools & Systems: Trackwise, Windchill, Agile, Veeva, Oracle, ERP systems
Quality Compliance Site Manager
One Diversified US
01.2019 - 01.2020
- Managed product compliance across domestic and international markets, ensuring readiness for commercialization and regulatory submissions.
- Directed complaint handling, NCRs, CAPAs, SCARs, and change control processes tied to product performance and customer experience.
- Reduced complaint backlog by 75% through data-driven process redesign.
- Oversaw technical files and documentation supporting product lifecycle and market access.
Sr. Quality Systems Supervisor – Quality Engineering
Fresenius Medical Care
01.2017 - 01.2019
- Led quality engineering teams supporting Class II medical devices and manufacturing operations.
- Directed risk management activities, change control evaluations, and product analysis.
- Managed utilities system redesign and qualification projects, delivering improved reliability and reduced testing cycles.
- Supported product release, wet chemistry analysis, and batch approvals.
Senior Quality Engineer – Quality Policy & Audit
Toyota Manufacturing North America
01.2016 - 01.2017
- Served as technical writer and policy owner for quality standards across North American manufacturing.
- Translated global engineering and quality standards into regional procedures.
- Led supplier recertification and quality audits across multiple sites.
Principal Quality Engineer / Program Manager (Onboarding)
Swiss American Products
01.2013 - 01.2016
- Led a $4.5M technology transfer for a medical device product, overseeing qualification, validation, and commercialization.
- Directed supplier quality programs, clinical trial support, analytical method development, and product testing.
- Managed cross-functional teams including Quality Engineers, Document Control, and Complaints.
Education
MBA - International Business Management
Dallas Baptist University
DallasB.S. - Biology & Chemistry
University of Arkansas
Pine BluffSkills
- EQMS/LMS: Trackwise
- EQMS/LMS: Windchill
- EQMS/LMS: Agile
- EQMS/LMS: Veeva Vault
- Data & Systems: Oracle
- Data & Systems: ERP systems
- Data & Systems: MS Office 365
- Data & Systems: Google Suite
- Clinical/Regulatory: Medidata Rave
- Clinical/Regulatory: TMF
- Standards: ISO 9001
- Standards: ISO 13485
- Standards: ISO 14971
- Regulations: 21 CFR 800
- Regualtions: EU MDD/MDR
Affiliations
National Society of Black Engineers
Certification
· Project Management Certification Series: PMP – Collin College, Plano TX
· CEU Training & Certificate of Completion: Medical Device Design History & Risk Management
· Certified Lead Auditor ISO 9001
Timeline
Staff Quality Systems Engineer (Technical Management)
Intuitive Surgical
01.2020 - Current
Quality Compliance Site Manager
One Diversified US
01.2019 - 01.2020
Sr. Quality Systems Supervisor – Quality Engineering
Fresenius Medical Care
01.2017 - 01.2019
Senior Quality Engineer – Quality Policy & Audit
Toyota Manufacturing North America
01.2016 - 01.2017
Principal Quality Engineer / Program Manager (Onboarding)
Swiss American Products
01.2013 - 01.2016
B.S. - Biology & Chemistry
University of Arkansas
MBA - International Business Management
Dallas Baptist University
Core Product Management Strengths
- Product Lifecycle Management (PLM)
- Requirements Gathering & User Needs Translation
- Technology Transfer & Commercialization
- Cross-Functional Leadership (R&D, Quality, Ops, Regulatory)
- Roadmapping & Prioritization
- Data-Driven Decision Making
- Supplier & Manufacturing Readiness
- Risk Management & Mitigation
- Voice of Customer (VOC) & Field Insights
- Global QMS Integration
- Validation & Verification Strategy
- Metrics, KPIs & Dashboarding
- Stakeholder Engagement & Communication
- Change Management & Process Optimization
Technical Skills
Trackwise, Windchill, Agile, Veeva Vault, Oracle, ERP systems, MS Office 365, Google Suite, Medidata Rave, TMF, Firecrest, ISO 9001, 13485, 14971, 21 CFR 800, EU MDD/MDR
Volunteer Leadership
- Board Chair, City of McKinney Community Grants Advisory
- Boys & Girls Club of Collin County
- Hope’s Door New Beginnings
- NSBE – National Society of Black Engineers
Personal Information
Title: Senior Product Manager