Daniel Lorey Email and Phone Number

- Technical program manager for several R&D programs with increasing complexity and responsibility over time, including organizing and running project teams, coordinating across multiple project teams to ensure an aligned product pipeline, providing technical support for regulatory submissions to US and OUS regulatory bodies, and ensuring all design control activities are completed prior to commercially launching product - Manages hardware and software focused cross-functional project teams of 30+ people from various departments such as R&D, UI/UX Design, Regulatory, Quality, Labeling, Clinical, and Marketing to ensure internal stakeholders are aligned and program schedules are adhered to - Leads design reviews and overall program updates with senior management to assess product development and regulatory submission timelines alongside commercialization strategy - Develops overall design control strategies specific to each new program, including design and development planning, Design History File structure and organization, and deliverable deadlines - Responsible for designing, organizing, and executing Human Factors studies (formative and summative) to assess product safety, efficacy, and usability as a part of an iterative design and development strategy

Acquired Invuity in Oct. 2018

- Owned project management responsibilities throughout the Design Control process for the design and development of Class II electrosurgical devices- Coordinated with cross-functional teams to identify project priorities, resources, and dependencies to aid development of detailed project deliverables and timelines - Developed high-level project status presentations and updates for management review- Collaborated with physicians to gather feedback and understand user needs to drive better product designs and features to improve overall customer experience

- Led cross-functional teams through all phases of the product development cycle for Class III electromechanical medical device systems used in diabetes treatment- Engaged with multiple functional groups during concept and feasibility phases to ensure opinions and concerns of key stakeholders are addressed early in the development process - Collaborated with Human Factors, Marketing, and Clinical teams to design clinical studies which gather data on customer burden and user needs, developing an understanding of the voice of customer to influence design decisions and improve product performance - Led technical reviews evaluating clinical and engineering data focused on various developmental efforts that impacted overall system performance, patient usability, and product reliability to ensure continuous product improvement - Designed experiments and clinical studies to gather data which answered questions critical to research and development effort

- Analyzed product complaints to determine potential regulatory reportability while maintaining the quality processes related to post-market product complaints- Performed root cause analysis to better understand whether the issue was an isolated event or related to an underlying product defect- Tracked occurrences of product failures and ensured that proper corrective action was taken when significant complaint trends informed an impact to customer quality of service- Troubleshot with customers to resolve product issues and confirmed device functionality