Jeff Steward Email and Phone Number

Product development consulting with the objective of helping teams to develop high quality, innovative new products, as quickly as possible.

Start-up medical products company specializing in novel pre-filled drug delivery combination devices. Responsibilities include engineering management, business development, operations management, and quality system development.

*Baxter Healthcare acquired Baxa Corporation in November 2011• R&D leader on the business integration team responsible for the smooth transition from Baxa Corporation to Baxter Healthcare.• Led new product development and lifecycle engineering in the Automated Filling Systems and Orals and Enteral Systems product lines.• Collaboratively drove the R&D and Quality organizations to simplify and clarify design control procedures, and align design controls to ISO 13485 and CFR820 standards.• Facilitated voice of the customer tools such as Quality Functional Deployment to clearly define the vision, and solidify cross business support, for new development programs.

• R&D Director for the Therapeutic Apheresis & Cell Therapy business unit: Product lines supported include Spectra Optia Apheresis System, COBE Spectra, COBE 2991 Cell Processor, Quantum Cell Expansion System, and Elutra Cell Separation System.• R&D leader in the Therapeutic Apheresis & Cell Therapy business unit management team. • Program Manager for development and delivery of Spectra Optia Therapeutic Apheresis platform. • Expedited regulatory submissions for all new Therapeutic products. This included US IDE and 510K submissions, and technical files for CE mark.

• Managed a new product development group responsible for the early development of novel catheter designs. Designs included drug delivery catheters, and drug eluting stents.• Worked closely with business development to evaluate potential novel designs. Rapidly assessed the viability of new product ideas in terms of their technical feasibility, market potential, and business fit.

•Development of new manufacturing processes for the CML family of Blood Oxygenators. Worked closely with New Product Development teams to co-develop manufacturing processes along with the development of new products.•Applied knowledge of Controls and Computer Aided Design to develop manufacturing equipment, including winding apparatus, pick and place machines, and automated assembly systems.•Supervised the Design Drafting Group. This team supported the entire development group with Unigraphics, Pro-Engineer, and AutoCad design tools.