Kimberly Robertson Email & Phone Number

Forest Lake, Mn, Us

Forest Lake, Mn, Us

Marlborough, Ma, Us

Part of an exciting group within BSC's Interventional Cardiology Division that focuses on identifying new opportunities. Currently Tech Lead of a large, cross-functional, exploratory project focusing on early clinical evaluation of safe product concepts.Prior work included leading a small team of scientists and engineers from Boston Scientific and the University of Minnesota's Medical Devices Center Innovation Fellows Program. • Developed new skills in defining market size / segmentation & reimbursement strategy. • Diligently followed the BioDesign Process to identify needs, create solutions, and gather market feedback on solutions. • Significant experience with learning a new disease state, ethnographic research in a hospital setting, intellectual property review, developing external relationships, and getting results without authority. • Leading innovation efforts including needs statement development, structured brainstorming, and solution filtering. • Led technical project management for rapidly growing project team within an exploratory environment to ensure appropriate task-work, teamwork, and knowledge-work planning.• Leading implementation of new Office 365 tools to enable team communication, task execution, and knowledge sharing.

Marlborough, Ma, Us

Moved to core team and workstream leader role supporting new opportunity in fully bioabsorbable stent technology. Helped pilot concept of internal start-up following the new Human Feasibility Assessment process. Concurrent primary R&D responsibility for DES coating and catheter design; led both DES Integration and Preclinical Workstreams. Led product spec and stability efforts. Compiled significant body of qualitative and quantitative preclinical and clinical data and conducted analysis to identify and solve key clinical use questions. Wrote significant portion of Design Dossier and DCD. Team received Corporate Knowledge Driven Product Development and Product Life-Cycle Process Awards.• Focused on maintaining high morale, engagement, and commitment while solving technical challenges on a very aggressive timeline • Concurrent primary R&D responsibility for DES coating and catheter design• R&D representative for Clinical and Preclinical work• Regular interaction with franchise leaders to provide feedback and ensure team is responding to evolving business needs• Regular R&D representative for IC Stents in the customer facing innovation center • Represented team in site-wide project education fair • Team earned numerous division-level awards and Corporate-level Knowledge Driven Product Development & Product Life-Cycle Process Excellence Awards• Continued involvement in TEC mentoring and NPD collaboration space management

Marlborough, Ma, Us

Moved to R&D Cardiovascular Balloon Catheters group to broaden technical knowledge base & gain experience working in a different part of BSC. Worked on technology development for IVUS catheter. Focused on gaining better understanding of the clinical need and design solutions. Continuous improvement effort includes development of low-cost technologies and components and integration of expertise located at two sites.• Developed competency in acoustic performance of polymers and fundamental catheter technologies• Regular customer interface to ensure design fit market/clinical need• Brought continuous improvement process from Operations to NPD• Led development of and launched new collaboration space for NPD• Nominated for and entered Technical Executive Committee Mentoring program as a mentee• Abele Award for development of Bioabsorbable coating

Marlborough, Ma, Us

Core Team Role on a large commercial development project for SYNERGY (a biodegradable coated DES), 2010-2012. • Key member of formulation development & coating characterization teams (see video below) • Identified as SME regarding dissolution & biodegradable coatings technology development, helping colleagues recognize the integrated nature of challenges and leveragability of prior work • Workstream Lead for Analytical Methods and Comparability (sub-teams of 6-15 scientists and engineers) helping others maintain focus and optimism during times of significant organization change • Lean approach to comparability (reduced cost by > 60% over prior demonstration) and spec setting (used historical data analysis to identify key design/process levers) • Significant contributions to Design Dossier, Drug Consultation Dossier, and IDE – demonstrating an understanding of the style and messaging required for written communication and conference call meetings with regulatory agenciesCore Team member on small, focused, Promus PREMIER Product Development Project team. Developed and received approval for iterative DES to meet business needs in a very short time, 2012-2013. • Successfully demonstrated comparability to predicate device with dramatically reduced time and cost, compared to traditional DES project • Significant contributor to Design Dossier update and PMA Supplement • Contributed to success of team by anticipating/mitigating R&D and cross-functional risks; lead the effort to develop unified strategies for parallel work • Knowledge Driven Product Development Leadership Award for effectively utilizing existing knowledge and strategic test plans • Winning Spirit Award for finding a workable drug-eluting stent design solution and receiving CE mark within 9 months • Team awarded Nicholas Award (highest-level corporate R&D award for financial significance)

Marlborough, Ma, Us

Technology development role for a novel biodegradable DES coating. Later became R&D Lead for Clinical Product Development Project (cPDP) and Technical Review Board (TRB) member for related TDP. • DES Workstream Lead (team of 12-15 individuals in R&D, PD, DA, Reg), setting high expectations and inspiring the team to exceed aggressive goals • Credited for transforming site-to-site working relationship, enabling a truly collaborative development environment and complete transfer of technical knowledge • Created modified design control and design change management systems to enable First Human Use clinical trial readiness • TDP sub-team received Corporate R&D Accomplishment Award for using a DFSS approach in a pre-clinical model to characterize histological response to variations in drug release profiles • Product Life Cycle Process Award given to cPDP sub-team for excellence in developing and testing 2 formulations of a novel, biodegradable coating in a First Human Use Clinical Trial • Team awarded highest level corporate technical contribution award (Abele Award)

Marlborough, Ma, Us

Extended team member supporting derivative biostable coated DES. • Developed competencies in dissolution, content, degradants, coating integrity, coating fatigue testing, particulates, preclinical evaluation, and other characterization techniques • Created novel approach to specification setting and batch sampling which saved over $2M per year and is still being used for all commercial DES • Awarded Outstanding Achievement Award in 2005 for being an individual who had demonstrated high potential within R&D

Minneapolis And St. Paul, Minnesota, Us

Assisted graduate students in Dr. Robert Tranquillo's lab in the field of tissue engineering. Also conducted independent research and developed test methods. • Learned techniques related to tissue culture, cryosectioning & staining for histomorphology, mechanical testing of tissue specimens and developed cell proliferation quantitiation method • Presented poster on mechanical impact of directional alignment of extracellular matrix at the Design of Medical Devices Conference (Mpls, MN 2003)

Master Of Arts (M.A.), Industrial And Organizational Psychology

Bachelor Of Science (Bsc), Bioengineering And Biomedical Engineering, Graduated Summa Cum Laude

Education record

Education record

Education record