Tim E. Ward

About Tim E. Ward

I’ve been given the opportunity to gain over 27 years’ experience in Medical Device Design, Development, and Manufacturing. Through strong technical and project management leadership, I have contributed to and/or successfully led teams in commercializing 14 medical device families to market. These product launches include internally developed, contract manufactured, and distribution only products worldwide in a strong matrix organization.Currently, I am working in a R&D New Product Development role leading new technologies to market within the Urology Pelvic Health division of BSC. Total Medical Device Design, Design Verification & Validation/ Total Process Qualification (Concept, DVMP, DVer, DVal, MVPlanning and Process PQ)Areas of anatomical experience: Urology, Womens health, and EndoscopyDevice design and development technologies of experience: Laser fiber and Systems, Retrieval devices, Drainage Stents-Catheters and Drainage systems, Irrigation systems, guide wires, Lithotripters, Needles and Access Systems, Dilatation Systems, and Mesh Delivery and Implants, Hysteroscopic devices.

Experience

1. New Product Development Engineering - Principle R & d

   Boston Scientific

   Mar 2019 — Present

   Lead Technical/ Engineering teams through complex new product developments using multiple phase development and product life cycle process. Work cross-functionally to foster and obtain collaboratory buy-in, to ensure strong deliverable vetting and robust documentation, in a highly regulated industry. Serve as SME on many of BSC Urology and Pelvic Floor Disorder devices. Mentor engineering talent and facilitate technical leadership trainings. Consult with engineering peers and management on the execution of Corrective Action/ Preventative Actions (CAPA), material changes, process changes, manufacturing support, VIPs, and component and finished product transfers. Collaborate cross divisionally on technology developments. Currently, I work remotely from the Bloomington/ Spencer Indiana (Manufacturing Facility) with direct reporting to divisional management in Minnetonka MN and the company headquarters in Marlborough MA.• Project Estimating• Project Scoping and Planning• Project Execution• Project prioritization• Provide technical and project mentorship• Identify Project mitigation & contingencies plans• Interact with internal and external stakeholders• Identify business risk & opportunity impacts• Conceptualize pipeline opportunities• Mentor and Facilitate Technical Leadership of engineering talent

Skills

• Fmea
• 21 Cfr Part 11
• Sustainability
• Validation
• Sourcing
• Biomedical Engineering
• Product Development
• Root Cause Analysis
• Problem Solving
• Change Control
• Dmaic
• Pmp
• Leadership
• Microsoft Office
• Design of Experiments
• Design Control
• Life Sciences
• Six Sigma
• Commercialization
• Cross-Functional Team Leadership
• Lifesciences
• Testing
• Quality Assurance
• Design for Manufacturing
• R&D
• Project Management
• Quality System
• V&V
• Gmp
• Fda
• Iso 13485
• Minitab
• Medical Devices
• Capa