Principal R&D Engineer, Interventional Cardiology @ Boston Scientific
Senior R&D Engineer, CV Balloon Catheters @ Boston Scientific
Senior R&D Engineer, DES Coatings @ Boston Scientific
Bachelor of Science (BSc), Bioengineering and Biomedical Engineering @
University of Minnesota-Twin Cities
A motivated, accomplished biomedical engineer with a passion for enhancing the quality of patients' lives through medical device development. Capable of quickly thinking through complex situations to generate ideas, develop plans, or resolve issues. Knowledge driven focus: treating information as a valuable asset, applying prior knowledge to new situations, openly sharing expertise and seeking the advice of
A motivated, accomplished biomedical engineer with a passion for enhancing the quality of patients' lives through medical device development. Capable of quickly thinking through complex situations to generate ideas, develop plans, or resolve issues. Knowledge driven focus: treating information as a valuable asset, applying prior knowledge to new situations, openly sharing expertise and seeking the advice of others. Able to target communication for a wide variety of audiences to achieve desired results. Reputation for learning quickly, retaining information, being creative, taking prudent risks, positively influencing team dynamics, and having a high degree of integrity, compassion, and authenticity.
Principal R&D Engineer, Interventional Cardiology @ Technical leader on new opportunity in fully bioabsorbable stent technology. Piloting concept of small teams working as start-ups within BSC as new technologies are investigated. Evaluating new Human Feasibility Assessment process.
• Focus 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
• Continued involvement in TEC mentoring and NPD collaboration space management
• Promoted to Principal Engineer in May 2014 From December 2013 to Present (1 year 11 months) Maple Grove, MNSenior R&D Engineer, CV Balloon Catheters @ Moved to R&D Cardiovascular Balloon Catheters group to broaden technical knowledge base & gain experience working in a different part of BSC. Currently working on technology development for next generation 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 new design was based on clinical need
• Introduced continuous improvement process to NPD
• Led development of and launched new collaboration environment for NPD
• Nominated for and entered Technical Executive Committee Mentoring program as a mentee
• Abele Award for development of Bioabsorbable coating From January 2013 to December 2013 (1 year) Maple Grove, MNSenior R&D Engineer, DES Coatings @ Core Team Role on a large commercial development project for biodegradable coated DES, 2010-2012.
• 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 agencies
Core Team member on small, focused 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 From January 2010 to January 2013 (3 years 1 month) Maple Grove, MNR&D Engineer II, DES Coatings @ 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 From June 2006 to January 2010 (3 years 8 months) Maple Grove, MNR&D Engineer I, DES Coatings @ 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 From May 2004 to June 2006 (2 years 2 months) Maple Grove, MNUndergraduate Research Assistant II @ 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) From 2003 to 2003 (less than a year) Minneapolis, MN
Master of Arts (M.A.), Industrial and Organizational Psychology @ The Chicago School of Professional Psychology From 2014 to 2016 Bachelor of Science (BSc), Bioengineering and Biomedical Engineering @ University of Minnesota-Twin Cities From 2000 to 2004 Additional Technical Training Kimberly Robertson is skilled in: Medical Device R&D, Combination Devices, Technology Development, Product Development, Technology Transfer, Formulation Development, Biostable &..., Device Characterization, Structured Problem..., Root Cause Analysis, Statistical Data..., Cross-functional Team..., Cross-functional..., Design Control, Design Change Analysis, Systems Approach to..., Quality by Design, Voice of the Customer, Product Positioning, Regulatory Writing, Technical Communication, Stability, Preclinical Evaluation, R&D, Design of Experiments, Formulation, Validation, CAPA
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