Stephen Foraste Email and Phone Number
Experienced Mechanical Engineer and Technical Project Manager.Leads complex design projects. 5 medical system product launches. Broad experience in electromechanical instruments, with 50,000+ units installed worldwide, and consumables, with 25M+ annual production.Manager for Junior Engineers and Interns. Proven ability to take on difficult technical challenges with precision assemblies. Start with incomplete information, guide multi-functional teams with structured problem solving to define design of experiments and data driven root cause analysis. Communicate project timeline and risks to stakeholders, and consistently produce successfully verified design outputs.I'm open to work in the Greater Boston Area, full time and contract roles, on-site, hybrid, and remote.stephen.foraste@gmail.comhttps://www.linkedin.com/in/stephen-forasteSkills:Project Management, Engineering Management, Precision Mechatronic Systems, FDA Design Controls, User Needs, Design Input Requirements (DIR), Product Specifications, Detail Drawings, Product Development Process (PDP), Research and Development (R&D), Failure Mode Effect Analysis (dFMEA, pFMEA), Prototyping, Corrective and Preventive Action (CAPA), Field Issues, Lifecycle, Kepner-Tregoe Method, Bench Test, Feasibility, Verification Testing, Validation, Traceability Matrix (IOVV), Risk Analysis, Severity, Occurrence, Detection, RPN, Hazard Analysis Risk Register, Critical Quality Attributes (CQA), EDO, CTF, Model Based Systems Engineering (MBSE), Risk Mitigations, Patent, Subject Matter Expert (SME), Independent Reviewer, Kick-Off, Design History File (DHF), Device Master Record (DMR), SAP, Agile, GD&T, Transportation, Atmospheric, EMI/EMC anechoic chamber, Offshore, handbook, Microfluidics, Cancer Diagnosis and TreatmentISO 13485, IEC 60601, ISO 9001, ISO 14971, CFR 820SolidWorks, TolAnalyst, NX, LabVIEW, MATLAB, Simulink, Minitab, ANSYS, DOORS, Zemax, Code VStaff Mechanical Engineer, Principal Mechanical Engineer, Senior Mechanical Engineer, Technical Manager, Project ManagerProjects involving Marketing, Clinical, Science, Regulatory, Systems, Electrical, Software, Service, Procurement, MFG, Labeling, and Quality.Manufacturing: CNC milling, turning, injection molding, EDM, casting, 3D printing, laser welding, ultrasonic welding, lithography, robotic, sheet metal, radioactive isotopes, yields, SQDIP, line balancing, Kanban, lean, six-sigma, control limits, disposables, fixturing, tooling, metrology, FAIRs, IQ/OQ/PQ, Audit Vendors, National Labs, GLP, TIR vibration FFT, NDT, calibration, Gauge R&R
Nextphase Medical Devices
View- Website:
- nextphasemed.com
- Employees:
- 118
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Senior Mechanical EngineerNextphase Medical DevicesWellesley, Ma, Us
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Staff Mechanical EngineerSiemens Healthineers Nov 2016 - May 2024Norwood, MassachusettsProject 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. -
Senior Mechanical Engineer, Advanced EngineeringHaemonetics Jun 2012 - Oct 2016Braintree, MaProduct 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.
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Principal Mechanical EngineerNortheast Biomedical, Inc. Jan 2012 - Jun 2012Tyngsborough, Massachusetts, United StatesConsulted 2 MIT scientists for potential commercialization of new non-invasive technology for blood analysis. -
Technical Manager (Promoted From Senior Mechanical Engineer)Qsa Global, Inc. Oct 2002 - Jan 2012Manage 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.
Stephen Foraste Education Details
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Manufacturing Engineering -
Aerospace Engineering
Frequently Asked Questions about Stephen Foraste
What company does Stephen Foraste work for?
Stephen Foraste works for Nextphase Medical Devices
What is Stephen Foraste's role at the current company?
Stephen Foraste's current role is Senior Mechanical Engineer.
What schools did Stephen Foraste attend?
Stephen Foraste attended Boston University, Boston University.
Who are Stephen Foraste's colleagues?
Stephen Foraste's colleagues are Jenna Bradley, Cpa, Cma, Pj O'connor, Carlos Morales, Jackie Bostrom, Luis Holguin, Michael Windham-Steele, Stacy Willey.
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