Kimberly Waller

About Kimberly Waller

15+ years of experience in preclinical, clinical, and human factors research. As the Director of Human Factors at Veranex, I am responsible for informing product design through end user insights and ensuring products comply with the Human Factors expectations of regulatory Agencies. I manage human factors studies throughout product development and guiding usability-focused regulatory communications and submissions. I specialize in human factors methodology, including heuristic evaluations, formative user studies, and HF validation studies, and provides strategic FDA usability guidance and support to medical device and pharma clients. I hold a Ph.D. in Biomedical Engineering from Brown University, a B.S. in Biomedical Engineering from Boston University, and a Dual Regulatory Certificate in Medical Device and Pharmaceutical from RAPS. Prior to joining Veranex, I held a research instructor position at the Warren Alpert Medical School of Brown University and Rhode Island Hospital, focusing on preclinical testing of a surgical device and intraarticular injection to repair and protect the knee joint following ACL tear.• Well-versed in the application of HFE and risk management guidance and standards (FDA Guidance, ISO 13485, ISO 14971, IEC 62366, HE75) to design and test medical device, drug, and combination products.• Experience in overall HF product strategy and the management and execution of formative and validation activities, development of labeling (e.g, instructions for use, quick reference guides, primary and secondary packaging, on device labeling), and FDA correspondence.• Practiced in risk management, including Human Factors Plan, comprehensive task analysis, URRA development, and benefit-risk analysis to support Agency applications. • Responsible for authoring and maintenance of HF-related SOPs, Work Instructions, and forms to ensure compliance to ISO-13485, CFR Part 820, FDA guidance, HE75, and IEC 62366. Experienced supporting audits conducted by clients, FDA, and ISO.• Experienced in HF remediation and post-market surveillance, as well as comparative analysis to ensure next generation products meet or exceed Agency expectations. • Experience planning, conducting, and supporting design validation activities, including the integration of functional design validation into HF validation, and master validation plans and reports.

Experience

1. Director of Human Factors Engineering

   Veranex

   Jan 2023 — Present · Providence, RI, US

   Organize and direct staff to support client Human Factors Engineering files, risk assessments (e.g, Use Related Risk Analysis (URRA), Usability Failure Mode Analysis (UFMEA)), and human factors testing, including heuristic evaluations, formative, and validation studies. • Manage current and prospective client relationships and programs, at the program management and business development levels, including cross-functional proposal writing across Veranex Business Units.• Attain product and application expertise on development teams, and communicate with team members, supervisory staff, content experts and regulators, to ensure compliance with regulations and guidance from FDA and international regulatory agencies.• Prepare regulatory submission documents or document sections for submissions to notified bodies either directly or through clients for human factors, usability, and design validation. • Manage the governing procedures for Human Factors Engineering, including leading integration of legacy Human Factors Engineering Standard Operating Procedures, Work Instructions, Forms, and trainings to ensure compliance with US and international standards and guidance documents, including IEC 62366, ISO 13485, ISO 14971, ANSI/AAMI HE75, and 21 CFR 820. • Develop departmental objectives, plans, policies/procedures, resourcing, oversight of HFE human subjects studies, and other requirements as Head of Clinical Affairs.• Contribute to projects and initiatives that support wider organizational goals, including internal review and oversight.• Recruit, develop, and retain high performing staff with a range of technical and leadership capabilities. Implement robust onboarding and career development pathways for staff that empower individuals to perform at their highest level.

Education

• Brown University

  PhD, Biomedical Engineering

  2008 — 2013

• Boston University

  BS, Biomedical Engineering

  2004 — 2008