Sue Huser

About Sue Huser

SUMMARY OF QUALIFICATIONSExtensive experience in medical device industry in R&D, Product Development, Program Management and Quality; additional experience in R&D at polymer manufacturers Substantial experience leading and directing cross-functional Product Development and Program Management teams with R&D, Quality, Manufacturing, Regulatory Affairs, Clinical Trials and MarketingHighly motivated, results oriented, team player with demonstrated leadership and management skillsProgressively increasing work scope and responsibilities to include program management of cross-functional, world-wide teams; fiscal oversight; project planning; strategic and tactical portfolio planning and executionExperience with polymers, extrusion, catheters, implants, combination products, and medical device systems• Innovation Process Leadership: Front End Discovery and Technology Development• R&D Leadership, Franchise• R&D Operations: Preclinical, Modeling, Design Engineering, Labs and Customer Experience (CX) R&D• PMO Leadership• Customer Centric Design Champion • Quality Leadership

Experience

1. Senior Director, R & d Operations

   Stryker

   Mar 2015 — Present · Fremont, CA, US

   Established the R&D Operations group in 2015; hired talent, developed talent for success, progressively making broader and more meaningful impact to the business. Grew group by 60% to 80 employees, expanded its responsibility to include International NV sites in four geographic areas, significantly expanded NV Engineering Services and Labs, built the Preclinical team to be the best in the business and an unique asset in all of SYK, added several new clinical immersion and training programs for R&D and cross-functional groups, and built the Customer Experience (CX) R&D group to support the R&D and Commercial Organizations. R&D Operations has supported over 35 new product launches in all the targeted International regions and is currently supporting 40 projects including Discovery, New Product Development, Sustaining Engineering (SE), Clinical, Global Quality & Operations (GQO) and other projects. Provided leadership of the R&D Operations group and stewardship of the Innovation Board over the last 8 years, resulting in NV being more customer centric, more collaborative within NV and the broader SYK enterprise. Set up NV R&D well to support a $2B organization, resulting in NV Preclinical being voted best R&D team at the 2019 Global R&D Awards. Participated on R&D Council’s Best Practices Front End Discovery workstream and the Customer Centric Design (CCD) workstream as CCD Champion for NV. Participated on Stryker Women’s Network (SWN) Steering Committee as Site Elect in 2020 and as NV SWN Site Lead in 2021.

Education

• Washington University in St. Louis

  BS, Chemical Engineering

  1983 — 1987

Skills

• Commercialization
• Fmea
• Gmp
• Validation
• Cross-Functional Team Leadership
• Iso 14971
• Iso 13485
• Fda
• R&D
• Quality System
• V&V
• Process Simulation
• Product Development
• Design of Experiments
• Medical Devices
• Capa
• Design Control
• Program Management
• Root Cause Analysis
• Biomedical Engineering