Jay Harper Email & Phone Number

Raleigh, Nc, Us

Responsible for providing overall strategic leadership for Global Project Management within Aesthetics Technical Operations. Worked closely with Global Leadership team to develop and apply processes for standardized and transparent Project Management across Global Manufacturing. Developing and implementing global metrics and reporting across the portfolio including but not limited to CAPEX, OPEX, process improvements, scale up efforts, site transfers and expansions, product transfers from R&D, manufacturing sustainability along with other strategic initiatives.

Denver, Colorado , Us

Developed and established NPI and Sustaining Project Management Office and supporting processes. Supported all functions in the development, implementation, and delivery of reprocessed Remote Patient Monitoring devices to achieve year end goal of delivering ~40k to critical partnership of Medtronic. Created ongoing method for tracking and delivering actions required to continually enhance and improve customer experience as well as improving the releases of current product. Drove improved process to reduce cycle time of full commercial releases in device Firmware from 3 months to 2 weeks. Utilized 6 sigma tool kit and knowledge to identify and implement process improvements for the labeling of wearable devices and the supporting equipment for SaaS and DaaS products.

Amsterdam, Noord-Holland, Nl

Developed improved Sustaining project oversight and site planning. Chair of Philips Sustaining Review Board, responsible for the reporting, execution and oversight of Discretionary Projects, Margin Expansion Projects, Large Supplier Changes (Site moves, onboarding of new strategic suppliers, etc.), maintaining supply continuity for the business. Partnered with Project Management to develop and build PMO for Sustaining activities. Worked with business category leads to identify project opportunities, supported management of site and category P&Ls. Key member of external and internal audit Strategy Room for responses during in-person, virtual, and desk audits. Developed and maintained strategic plan of record, annual operating plan and project pipeline for 15 product families and 105 SKUs. Reviewed and accepted Design Transfers of new product development projects. Applied MDR transition experience and knowledge to support other Philips sites achieve MDR registrations. Executed site closure and transfer of a DHF relative to 11 SKUs. Built team of 14 teammate for a Sustaining organization that was previously non-existent, built capabilities and skills for an R&D that has a 3 year track record of meeting and exceeding corporate Operations and Sustaining Engineering objectives.

Amsterdam, Noord-Holland, Nl

Sustaining R&D supporting the Operations and Manufacturing of all Product Lines produced at the Colorado Springs facility (14 Product families, 101 SKUs). Responsible for department and laboratory budget. Member of Program Team responsible for establishing site priorities and objectives for 2019 and 2020. Developed and established the Sustaining strategic planning and roadmap and organizational infrastructure to support Annual Operating Plans and Strategic Plans of Record for 3 separate business units relative to site (Heart Rhythm Management, Coronary Vascular, Peripheral Vascular). Evaluated and provided resources for Corrective and Preventive Actions, Non-conformance Reports, Supply Chain stability management and general product manufacturing efforts. Revised Quality Management Systems, Design Controls and Business Process to incorporate desired Philips Central Team Ways of Working and desired procedures. Managed review and remediation of design history files for all product lines affected by transition from MDD to EU MDR.

Program Team Leader supporting the planning and development of business unit strategies for new product development and project execution. Incorporated new electro-mechanical lead removal device into business portfolio and long term strategy, including full launch, commercial and podium strategies. Responsible for budget of $8M in project expense and $1M in project capital. Developed and maintained timeline to achieve business unit objectives of new product launch at Heart Rhythm Society 2019.

Colorado Springs, Colorado, Us

Remediation Program Team Leader supporting the planning and remediation for Process Validation and Design Inputs/Outputs of class II and III catheters for use in Lead Management and Vascular Intervention businesses. Responsible for project planning, budgeting and scope. Managed a large team of Engineers and Contract Employees to achieve desired result of product family Process Validation remediation meeting stretch goals. Successfully partnered with Manufacturing and Quality departments to remediate 1 class III (PMA) product family with 7 SKUs meeting stretch goal of audit readiness for FDA, and 2 class II products. Generated a strategy to evaluate 3 different designs and assembly processes to execute Process Validation for audit readiness and PMA 30-day notices for implementation prior to FDA re-audit. Directed development of Design Input/Output remediation plan and execution for 19 year old project files, including 2-year Design Verification testing and Product Performance Qualification testing as part of the Process Validation. Enhanced Post-Launch Change Management system to comply with CFR and ISO requirements as a result of FDA form 483 letters. Reviewed, evaluated and developed a plan for 17 legacy product families (dating back to 1997) Design Inputs and Outputs documentation remediation.

Colorado Springs, Colorado, Us

Core team leader supporting the development and launch of class III catheters for use in Lead Management businesses. Responsible for project planning, budgeting and scope. Successfully partnered with Marketing teammate to evaluate market opportunity for novel Class II and III medical devices. Developed and executed on project timeline and strategy from Concept through Launch of novel Class II Medical Device (Bridge Occlusion BalloonTM). Successfully launched product in 8 months (FDA approval in 6 months), achieving stretch goal and maintaining budget. Developed and successfully executed a strategy to launch 3 months early for an Investigational Review Board (IRB) study to gather clinically relevant data for Heart Rhythm Society podium discussion boards. Incorporated an accessory kit within 4 months for the Bridge Occlusion BalloonTM to facilitate use and adoption during launch and commercialization without additional impact to timeline. • Worked with physicians on publications for both GLP Animal Lab Study and Human IRB Study and providing conduit to Engineering team and organizational resources to support publications for Heart Rhythm Society Podium speakers and launch. Ensure compliance with local and international regulations (21 CFR 820, ISO13485), corporate quality systems, cGMPs, GLP.

Colorado Springs, Colorado, Us

Core team member supporting the development and launch of class III catheters for use in Vascular Intervention and Lead Management businesses. Responsible for Risk Management, Human Factors and Test Method Validation. Created Risk Assessment Libraries (PHA, DFMEA,PFMEA, UFMEA) for Class II and III Medical Devices. Authored work instruction for statistical approach to Test Method Validation. Supported creation of Test Methods for Verification Activities. Successfully complete new product development tasks – create product specifications, BOMs, component inspection methods, test methods, Design Inputs and Design Outputs creation. Ensure compliance with local and international regulations (21 CFR 820, ISO13485), corporate quality systems, cGMPs, GLP.

Indianapolis, Indiana, Us

Supervisor of Engineering team performing detailed investigations of product return complaints. Validation business process owner and Packaging Process Validation trainer. Root Cause Analysis lead investigator. Lean Six Sigma Green Belt. Maintained and revised Corporate Common Quality Practices for Process Validation to enhance assembly process performance specific to Medical Device Manufacturing Process Validation. Owned Design and Manufacturability Review business process to ensure on time resources allocation and thorough review of current development projects. Key team member on Process Validation Improvement Project ensuring FDA Compliance. Chaired Validation Center of Excellence technical forum to create common practices and governance. Lead Investigator for Root Cause Analysis Investigations to identify manufacturing process improvements. Trainer for Packaging Process Validation Intensive program.

Indianapolis, Indiana, Us

Consultant on research and development projects for novel large molecule delivery devices. Providing input and engineering support on the development and launch of class I and II medical devices. Managed contract manufacturing relationships and assembly linesOwned project risk management portfoliosParticipated as independent reviewer on a number of development projectsProvided insights to US customer interactions and product desiresCoordinated outside the US human factors study for an iteration of an existing insulin delivery deviceKey member of a 6-sigma process improvement team in increase the efficiency of the decision making process during device development

Indianapolis, Indiana, Us

Responsible for providing diabetes care solutions to primary care physicians, specialists and other health care providers that manage patients with diabetes.2009 Central Area District Portfolio Award (100% to Quota)Achieved *Maroon* level award for obtaining 70% market share of Humalog sales.Earned District Achievement Quota trip for exceeding 100% to quota and #1 District in AreaEarned Brand Team recognition for managing and developing relationships within my territory to exceed 60% market share objective.Implemented patient education programs between physicians* offices and Certified Diabetes Educators.Managed planning and implementation of successful national thought leader programs for local market.

Indianapolis, Indiana, Us

Lead engineer for design development and launch of class II pharmaceutical delivery devices. Responsible for design development planning, verification and validation requirements. Recognized for contributions to the development of a novel insulin delivery device by CEO of Eli Lilly and Company.Transferred three medical device projects to successfully marketed products.Created and Maintained Development Plan for a novel Human Growth Hormone Device.Organized and coordinated product development timelines for multiple pen test systems.Administered operations of daily engineering projects, studies, and protocols.Conducted engineering analyses to ensure quality and user friendliness. Coordinated Quality Engineering efforts for the development of novel pharmaceutical delivery devices. Conducted operation assessments and manual assembly equipment fabrication.Key team member on multiple Six Sigma Process improvement projects.Consulted with certified diabetes educators and nurse educators to develop better diabetes care and management programs for patientsTrained, supervised and mentored new staff members Managed international design validation project for development of pharmaceutical delivery device

Indianapolis, Indiana, Us

Directed and organized quality and test engineering processes for class I and II pharmaceutical delivery devices. Participated in planning and technical execution of Phase 3 Clinical Trial.Conducted Engineering studies and reported results to management.Provided customer input via market research and user studies to the Lilly/Amylin Byetta Product Launch TeamDirected and organized quality and test engineering processes for medical devices.Organized and presented protocol for Validation and Verification procedures for the development of pharmaceutical injection devices.

Indianapolis, Indiana, Us

Received the Statistical Thinking Award Developed a solution for reconstitution device supply chain damage.

Conducted Design and Test Engineering.

M. S., Strategic Management

Masters Certificate, Project Management

M. Eng., Management Of Technology

Bachelor Of Science, Engineering Science