Mark St Germain Email & Phone Number

Dunstable, Ma, Us

Boston, Ma, Us

Amsterdam, Noord-Holland, Nl

Operations / Supply Chain Management• Program Lead for Multiple Medical Device Manufacturing Operation Moves including to India (Opto Circuits) and Costa Rica (Philips Volcano)• Executed Supply Chain cost analysis• Responsible for maintaining assurance of supply for customers during operational transfers• Successfully led manufacturing transfers in compliance with Philips Quality Management system • Applied Lean Principles in form of Daily Management for timely issue tracking and resolution• Led strategic planning for inventory management, Supply Chain Risk Mitigation • Led supply chain DFx style workshops in Germany with cross functional participation• Created and execute cost saving/ risk mitigation for portfolio • Program lead for driving multiple-wave dual source strategy • Instrumental in escalating and driving decision to change sourcing strategy from China to Mexico to overcome regulatory roadblocks. • Led the investigation and qualification of 2nd source suppliers. Current Product Engineering / Sustaining • Led Cost Savings-DFx workshops and maintained cost savings funnel for portfolio• Developed / executed project plans for Product Design Changes to Improve Quality, Reliability and Serviceability.• Lead monthly program management reviews • Organized the resources to be used (quality, time, allocation, budget, and information)• Identified the risks associated with sustaining project (specs, costs, planning, etcetera) and develops scenarios to overcome these risks by defining corrective actions and driving the projects to closure • Managed the Deployment of process improvements at suppliers and supported the continuous improvement of his teams • Piloted and implemented E2E risk management is his sustaining projects

Amsterdam, Noord-Holland, Nl

New Product Introductions• Proven track record of establishing comprehensive Project Plans for the development and commercialization of finished medical devices. • Responsible for Project Charters and partnered with Marketing on creation of Business Cases• Led the development of Design Input documents including Customer Requirements Specifications, System Requirements Specifications, and Risk Documentation• Led Project Reviews including Design, Design History File, and Management reviews• Led cross-functional teams consisting of worldwide suppliers, cross-divisional engineering, product marketing, supply chain, and quality/regulatory • History of developing and commercializing medical consumables Advanced Development • Program Manager for a novel UV Pulse light disinfection technology platform “LumiShield™ designed to prevent infection at catheter penetration sites.• Responsible for the selection and management of a vast network of suppliers, 3rd parties, laboratories, and clinicians • Oversaw clinical studies to demonstrate the Antimicrobial Efficacy of the Philips LumiShield system • Led the Risk Management of the UV Pulse technology• Selected, Partnered, and managed relationships with 3rd Party design houses Clinical Studies / Usability-Human Factors / Verification and Validation• Managed significant level of Biocompatibility Testing and Cleaning / Disinfection testing with 3rd parties • Managed Usability - Human Factors Validation testing with 3rd parties • Responsible for Safety related testing for product releases including EMC, Immunity, and Emissions• Selected and Managed clinical studies performed for Philips UV Pulse Disinfection system

Santa Clara, Ca, Us

Palo Alto, Ca, Us

Provided direct engineering support to the Operations and R & D departments through innovative process and product development, and continuing maintenance of two disposable medical device products, an Intra-Aortic Balloon Catheter and Centrifugal Blood Pump. Successfully coordinated and managed engineering projects that involved the development and or redesign of the IAB catheter and centrifugal pump. Project management responsibilities included meeting and maintaining project timelines, qualification of injection molds and processes, development or redesign of new tooling for IAB components including the catheter tip, Taper Seal sheath, bifurcate, syringe, and check valve components. Supported development of new super elastic alloy inner lumen material, process development of hydrophilic coatings, IAB bonding processes, optimization of ultrasonic welding processes, and numerous other manufacturing and packaging processes to continually improve overall manufacturability. Extensive background in performing design of experiments to aid in the development of new processes and used often as a tool in troubleshooting and performing FMEA analysis of manufacturing processes / designs.Quality Assurance duties included the development and writing of Feasibility studies, Design Freeze, Design Verification, and Process Validation protocols and reports that met latest FDA GMP requirements. Successfully implemented into production critical 510(k) design changes of the centrifugal pump, a Class 3 medical device.

Master Of Science - Ms, Manufacturing Engineering

Bachelor Of Science - Bs, Mechanical Engineering

Minor, History