Stephen Foraste Email & Phone Number

Wellesley, Ma, Us

Norwood, Massachusetts

Project Manager for the Sensor Cartridge, the heart of the future blood gas analysis instrument line. This instrument line competes with the market leaders of Abbott and Roche, and has over 30,000 machines generating $1B annually. First new blood gas instrument from Siemens since the 90’s. Patent application under review by outside counsel.Subject Matter Expert on the Measurement Cartridge, the heart of the legacy blood gas analysis instrument. dFMEA of entire assembly, with respect to both basic science, and empirically learned challenges for this product earning revenues of $1M daily. Tooling sustainability and improvements to address the identified challenges for both customer satisfaction and production yields.Independent Reviewer on many mechanical and fluidic systems for new product development projects, and current products for Point of Care (POC) instruments used worldwide.

Braintree, Ma

Product Manager for a complete redesign of a blood processing centrifuge. This machine is the world leader, with over 15,000 machines generating $350M annually. Determined that a new design would allow improved design for manufacturability, durability and cost. Most importantly, the new design allows for very precise adjustments to align the disposable bowl with the centrifuge axis, therefore providing smoother operation for current rotational speeds as well as higher speeds in future protocols.o Assemble the required team and Kick-Off the project with buy in from all departments.o Revising the Product Requirements Document for this legacy device, to capture the required mechanical specifications.o Complete design documentation, with reference to the Requirements Specifications.o Determine the IOVV Traceability matrix, author and manage all the Verification testing.o SolidWorks modeling with the necessary geometric dimensions and tolerancing (GTOLS) to manufacture these 200 components and the fixturing to assemble and tune this mechanism all within a few thousandths of an inch in field locations with minimal training and tooling.o Source the prototypes, contract for the First Article Inspections.o Work with outside firms for Transportation, Vibration and Atmospheric testing.o Complete the project as a proper auditable chapter within the Design History File.

Tyngsborough, Massachusetts, United States

Consulted 2 MIT scientists for potential commercialization of new non-invasive technology for blood analysis.

Manage technical projects for all Sources products. Champion sales leads with expert design and applications advice for customers, regulators, engineering and manufacturing.- Designed and managed the fabrication and installation of a Hot Cell (shielded enclosure) capable of producing the entire world demand for High Dose Rate (HDR) Brachytherapy Ir-192 sources to be inserted into catheters for cancer treatment. This lab was the biggest company project and was recognized at an awards ceremony at our parent company headquarters in the UK. The lab now supplies over 60% of the world demand, generating revenues over $3M annually. The lab went from blank sheet of paper to commissioning in 9 months, on time and $50k under our budget of $750k. Created and maintained the Design History File and the Device Master Record to ISO9001 and ISO13485 standards to comply with FDA cGMP 21 CFR 820 regulations- Redesigned the C-Thru™ Flood Source product line of inkjet printed sheets with uniform radioactivity used to calibrate gamma cameras used in hospitals for cancer diagnosis.- Redesigned a Sr-90 calibration standard to ensure patients receive the correct Y-90 dose for the treatment of non-Hodgkins lymphoma.- Interface with vendors to audit capabilities and make process improvements at national labs, including Oak Ridge, Los Alamos, Pacific Northwest, NPL (UK), Mayak and RIAR (Russia)- Manage 30 years of intellectual property when negotiating with key suppliers.

Ms, Manufacturing Engineering

Activities and Societies: SME

Bs, Aerospace Engineering

Activities and Societies: Senior Class Treasurer AIAA