Chris Schaffer Email & Phone Number

Palm Beach Gardens, Fl, Us

Palm Beach Gardens, Florida, United States

Lead the Project Management Organization for project activities related to new product development.

Palm Beach Gardens, Florida, United States

Senior Staff Project Management role within the Depuy-Synthes Orthopaedic business unit serving NPD, special projects, PMO infrastructure management and staff meeting facilitation, and management of Power Tools business unit NPD and Sustaining resource allocation.

West Palm Beach, Florida Area

Participate in the development of business requirements, define project objectives, and develop end to end project plans, schedules, and budgets. Plan, prioritize, and coordinate project activities to ensure timely deliveries. Perform resource allocation, workload assignment, and schedule management activities to meet project milestones. Identify project risks and develop appropriate mitigation and contingency plans. Oversee and provide direction to daily operations of project teams, and report status to executive leadership.

Gainesville, Florida Area

Lead site specific and enterprise wide compliance initiatives, and enterprise wide systems initiatives.

Cordova, Tennessee

Lead extremities and limb restoration NPD core teams through the development and launch of orthopaedic surgical systems comprised of implants and instrumentation. Guide and facilitate cross-functional teams through design control and phase review discipline processes. Manage project scope and milestone schedule, assess risk and facilitate the formulation of mitigation plans, resolve conflicts, and assure healthy team dynamics. Interface with business unit leaders on the product portfolio to develop launch and phase out strategies, and present status of programs to executive leadership.

Cordova, Tennessee

Lead direct reports and cross-functional S&N and supplier manufacturing site teams in the development and transfer of Trauma & Extremities new product designs into manufacturing. Assess internal equipment capacities, draft capital equipment requests with finance, create and maintain program budgets, oversee the formulation of engineering study and validation plans and schedules, determine and support the implementation of staffing requirements for execution. Assess annual project loading with leadership and appropriately staff engineering team, develop engineering team resources, and create and support direct report career framework.

Memphis, Tennessee

Lead cross-functional S&N and supplier manufacturing site teams for manufacturing transfer of Orthopaedic Reconstruction and Trauma implants and instruments worldwide. Manage S&N stateside and China site project engineering direct reports, train and support manufacturing sites on manufacturing transfer process, oversee product and program costing and capital expenditure requests, coordinate and support the movement or purchase of manufacturing equipment, oversee equipment qualifications and process validations, and oversee cut over planning with cross-functional resources.

Tijana, Mexico

Lead and develop program manager and project engineering direct reports assigned to new development and sustaining customer programs. General oversight and support of program teams comprised of program management and project engineering direct reports and cross-functional resources from quality, supply chain, tooling engineering, process engineering, operations, maintenance, and sterilization engineering. Implement, train, and maintain program management tools, systems and methods. Manage departmental finances, participate in management reviews as mandated by ISO 13485, participate in the identification and execution of cost and quality improvement initiatives. Ensure adherence to ISO 13485 requirements for vendor supplied components, injection tooling, fixtures, semi and fully automated assembly solutions, and production lines. Review and approve program validation master plans, review and approve IOP protocols and reports for injection molding, assembly equipment, manufacturing lines, and ETO sterilization validations. Prepare and present new program proposals comprised of capital equipment and finished good pricing, support corporate sales and executive leadership in efforts to win business. Prepare quotations and program proposals and sell direct production line manufacturing solutions, injection molding tooling, assembly equipment, validation activities, and various engineering services.

Scottsdale, Arizona

Lead and manage medical device program teams comprised of direct report technical resources, supply chain, injection molding tooling, injection molding process engineering, automation/assembly engineering, quality/validation, and manufacturing plant resources. Source and procure quotation for component level product per customer design requirements for drug delivery and other medical devices. Facilitate internal and external team meetings, and act as primary customer contact for program updates and dispute resolution. Ensure program team adheres to NPD ISO procedures, ensure adherence to relevant FDA and cGMP requirements, and monitor program resource activities to ensure adherence to program plan. Create, maintain, and communicate program schedules in MS Project, create and maintain program development plans, assemble and distribute quotations for large program proposals and engineering services and equipment, perform contract reviews, and receive and process customer and intercompany purchase orders and CER’s. Establish program budgets, and perform program cost accounting to monitor vendor and customer progress payments and program resource time tickets. Evaluate engineering part FAIR, DOE reports, and statistical capability reports generated in Mini-Tab for injection molding process development and tool steel nominalization. Review and approve program VMP, mVMP, aVMP, injection molding IQ/OQ/PQ protocols and reports, supplier PPAP’s, and automation URS, FS, DQ, FAT, SAT, and IQ/OQ/PQ protocols and reports.

Bachelor Of Science, Mechanical Engineering

Education record