SUMMARY:

• Extensive hands on experience in biotech, high technology and medical product manufacturing, R&D, and service environments.
• Technical and managerial experience in a variety of different organizations from start - ups to Fortune 500 companies.
• Hands on technical expertise includes vacuum Confidential, p.c. board assembly, optical package assembly and testing, fluidics, pneumatics, water filtration and biomedical research and process equipment of all types including assembly, repair and refurbishment.
• Extensive experience in microcomputers, from assembly to troubleshooting, repair and system integration.
• Software knowledge of varying degrees in MS Office Suite, MS Visio, Visual Basic, Lab View, a variety of Windows OS up to and including Windows 10, Merant Version Manager, DOORS, Statgraphics, Solidworks, Creo Elements/Direct Modeling.
• Familiar with SAP, ASK MANMAN, SYTELINE, 4th SHIFT and BAAN ERP packages.
• Participant in LEAN manufacturing, Six Sigma and Kaizen (Continuous Improvement) initiatives.

PROFESSIONAL EXPERIENCE:

Confidential, Billerica MA

Manufacturing Engineer / Production Supervisor

Responsibilities:

• Provide engineering support for the rebuilding and refurbishment of vacuum Confidential and related equipment.
• Expertise includes scroll pumps, rotary vane pumps, turbo-molecular pumps, helium leak detectors and vacuum gauge controllers.
• Created and updated work instructions to aid in the refurbishment of various types of vacuum pumps.
• Provide Product Support Engineering services for client companies.
• Supervisory tasks as required.

Confidential, Wilmington,MA

Mechanical Process Engineer

Responsibilities:

• Developed mechanical fixturing, designed modifications and documented changes to existing and duplicate filling equipment.
• Created and modified Solidworks drawings of new and existing mechanical components.
• Assisted in evaluation testing and determining functionality of duplicate filling equipment based on existing equipment validations.
• Coordinated with outside vendors to facilitate the fabrication of mechanical parts.
• Support to the manufacturing operation as required.

Confidential, Shirley, MA

Project Engineer / Technical Writer, Contract Assignment thru Blacktree Technical

Responsibilities:

• Contracted to expand the troubleshooting section of the existing CT Scanner service manual.
• Spent extensive touch time on the Mobius CT system to develop technical knowledge of the hardware, software, electronic and mechanical functionality.
• Expanded upon topics in the Service Knowledge Base, added additional material to aid service engineers in system troubleshooting.
• Validated and edited manual segments as required for functionality, accuracy and clarity.
• Added approximately 70+ pages of information to the service manual.
• Wrote and modified service processes, created Technical Service Bulletins and ECO’s as required.

Confidential, Lexington, MA

Senior Manufacturing Engineer - Expert Level

Responsibilities:

• Previously worked with the organization as a contract Manufacturing Engineer when the organization was Confidential Vacuum Confidential .
• Sustaining manufacturing engineer for the Instruments Department.
• Lead Manufacturing Engineer in multiple product transfer projects to Malaysia and Italy.
• Wrote and improved assembly procedures for thermocouple gauges, active vacuum gauges, vacuum gauge controllers and helium leak detectors with an emphasis on lean manufacturing techniques.
• Represented manufacturing as part of new product introduction (NPI) team in the Instrument and Leak Detection departments.
• Developed and wrote manufacturing plans for new products.
• Coordinated with outside vendors on testing, quality and material issues.
• Created ECO’s, structured BOM’s, created and modified product routings using SAP.
• Fabrication of electrical, mechanical and vacuum test fixtures in support of the manufacturing operation.
• Developed floor plans and line layouts for new product introduction, including a class 10000 (ISO class 7) clean room.

Confidential, Westminster, MA

Manufacturing Engineer / Process Engineer

Responsibilities:

• Hired to help facilitate transfer of product lines from Westminster MA to Brownsville TX and Matamoras Mexico.
• Analysis and documentation of the internal Service Returns (RMA) process.
• Developed new processes for the testing, repair and refurbishment of legacy fire alarm and security Confidential .
• Created and updated test, assembly and system processes for manufacturing.
• Participant in formal Kaizen events to improve and streamline existing processes.

Confidential, Lexington, MA

Manufacturing Engineer

Responsibilities:

• Sustaining engineer for the Instruments Department.
• Developed and mapped manufacturing processes utilizing Laser, GTAW, Resistance and TIG welding.
• Wrote and modified assembly procedures for thermocouple gauges, active vacuum gauges and vacuum gauge controllers with an emphasis on lean manufacturing techniques.
• Prepared validation protocols, FMEA’s and performed engineering studies to develop and solidify product specifications.
• Manufacturing representative within a cross-functional group as part of new product introduction team.
• Created and modified drawings utilizing Solidworks.
• Created ECO’s, structured BOM’s, created and modified product routings using SAP.
• Supervised assembly and test personnel and coordinated production and engineering jobs thru the Instrument Department as required

Confidential, Billerica, MA

Manufacturing Engineer

Responsibilities:

• Hired to support manufacturing while operations were transferred to plants in California and Costa Rica.
• Engaged in a wide variety of engineering projects/programs in support of manufacturing operations.
• Involved in late stage design projects to facilitate transfer procedures.
• Provided technical guidance and expertise to solve a range of engineering problems.
• Using statistical methodologies, (DOE, Comparison of Means, ANOVA, etc.) prepared and executed engineering studies, product, process and equipment validations. (IQ/OQ/PQ)
• Designed and modified test fixtures and equipment.
• Managed manufacturing equipment preventative maintenance.
• Responsible for facilities maintenance and management, including HAZMAT related tasks.

Confidential, Lexington, MA

Software QA, Test Case Writer

Responsibilities:

• Black and gray box testing of pc based blood coagulation analyzers.
• Wrote software test cases to validate software developer adherence to engineering specifications.
• Prepared blood coagulation assays to facilitate software testing.
• Analysis of electronic block diagrams and schematics to test the error handling capability of software.
• Repair of blood coagulation analyzers as required.
• Utilized PVS Tracker, Merant Version Manager and DOORS for documentation, defect and specification management.
• Assisted less experienced test case writers and test case runners as required.

Confidential, Bedford, MA

Production Supervisor / Manufacturing Engineer

Responsibilities:

• Supervise 2nd shift production including a Class 10000 clean room environment.
• Directed the activities of employees in wire bonding, package assembly, laser weld, lens align, fiber pig-tailing and test functions.
• Wrote manufacturing procedures and ECO’s to current procedures as required.
• Troubleshooting of process problems and repaired shop equipment.
• Maintained WIP report and key manufacturing metrics with the departure of the Operations Manager.
• Assumed responsibility for the production control function with the departure of the Production Control Coordinator.
• Key player in helping organization attain goal of over 1200 units per month.

Confidential, Marlborough, MA

Production Supervisor / Manufacturing Engineer, High Throughput Screening

Responsibilities:

• Supervise 3rd shift high throughput screening operation of natural and synthetic compounds utilizing capillary electrophoresis. (laser induced fluorescence and uv absorption).
• Train employees in the preparation of reagents and buffers, instrument operation, lab procedures and the use of common lab equipment.
• Utilized Tecan and Caliper Life Science liquid handling equipment for high volume microtiter plate preparation.
• Responsible for the hiring and performance evaluation of employees.
• Troubleshooting of instruments and screening assays.

Confidential, Stafford, TX

Production Manager

Responsibilities:

• Reported to the Director of Manufacturing.
• Managed 30 assemblers, SMT machine operators and technicians in a medium volume, high mix surface mount, thru hole and hybrid p.c..board assembly operation on two shifts.
• Capital equipment responsibility included two Zevatech 540 pick and place machines, Europlacer 9000 and 4000 pick and place machines, Universal dip inserter, axial component inserter, radial component inserter and chip shooter.
• Managed a production schedule consisting of over 200 different types of P.C. boards, delivering requirements on or before scheduled.
• Established key metrics for determining capacity and machine utilization time to improve productivity.

Confidential, Framingham, MA/Houston, TX

PE Biosystems - Depot Repair Coordinator / Engineer II

Responsibilities:

• Scheduled and supervised the refurbishment, upgrading and repair of biomedical instrumentation.
• Supervisory responsibility over the activities of 3 in house service engineers and one material handler.
• Maintained inventory of new and returned service parts.
• Interfaced with manufacturing, production control and materials group on shortages and related issues.
• Direct customer contact to address problems and complaints.
• Wrote and implemented process and test procedures for ISO 9000 .
• Provided technical assistance and work assistance on instruments as required.
• Repair, refurbishment and upgrade of various types of biomedical lab equipment (PC and SUN based).
• Field service to local customers.
• Set up and maintained in-house repair depot for customer instrument returns.
• Assisted R&D in establishing manufacturing acceptance criteria for new products.
• Fabricated electronic and fluidics test fixtures from schematics and blueprints.
• Pressure and flow testing on production and prototype fluidics subassemblies.

Confidential, Boxborough, MA

Assembly Supervisor

Responsibilities:

• Directed the activities of up to 20 assemblers on two shifts.
• Responsibilities included p.c. board assembly, electromechanical assembly, cable and harness assembly and final assembly.
• Screened employment applicants and wrote employee performance evaluations.