Manufacturing Engineer Medical Device

Andrew J. Bonina

Gloucester, Mass ***** **********@*****.*** Cell: 978-***-****

EXECUTIVE SUMMARY:

Manufacturing Operations Engineer with more than 30 years of hands-on experience in research development and manufacturing in the Medical Device, Semiconductor, and Commercial Industries.

Certified Lean Expert though the University of Kentucky. Introduced Kaizen events/activities, Lean philosophies in a meaningful way to continually drive growth, profitability and the elimination of waste. Medical Device experience with (NPI) New Product Introduction, (DFM) Design for Manufacturing and (DFA) Design for Assembly. I worked on both Semiconductor and Medical Devices from conception through commercialization.

Strong background with Process Validation, Cost Reduction, Electrical Trouble Diagnostics and Agile Master Documentation Electronic ECO Systems including Oracle ERP Systems.

PROFESSIONAL EXPERIENCE SUMMARY:

Design for Manufacturing (DFM) Supplier-based manufacturing/process/quality issues.

ISO, FDA, and GMP requirements Specified and Purchased Capital Equipment

New Product Introduction (NPI) Expert in Facility set up and Product Transfer

Certified to the ISO 9001:2000 Standards. Certified to the ISO 13485:2003 Medical Device Standards. Lean Six Sigma Training/5S Disciplines Lean Certified / Auto Cad / Solid Works

PROFESSIONAL EXPERIENCE:

L3 Technologies (Formally Implant Sciences) Wilmington, Ma.

Manufacturing Engineer 2015-Present

Implemented and installed computers on the production floor creating a paperless system with the ability to access any document directly from the company server.

Designed and developed a semi-automated tooling ergonomic production Lean line for Sieve Canisters, increasing revenue from 3 Million to 13 Million yearly.

Created 98% of the manufacturing assembly procedures for the B220 Detection system.

Initiated an ESD program for production, inspection, test, service and repair departments.

Reduced the cost of our consumable products with the elimination of IPA from the cleaning process by 40%.

Acted as a Supervisor on the manufacturing floor and liaison reporting to the Production Manager.

Established a Lean manufacturing line transitioning our new H150E Detection System from R & D to Production, including writing all of the manufacturing procedures, test stands, time studies and routings.

Essential member of the team that assisted in the approval of ISO 14001 Environmental Certification.

Member of the Engineering Change Order and MRB boards.

Validated and implemented new components such as the Hand Touch Display and Vibration Mounts that were consistently failing in the field or end of life critical components.

Hillside Engineering Danvers, Ma. 2015-2015

Manufacturing Engineer

Responsibilities included creating procedures, wire lists, routings, & inspection criteria check lists for complex camera and transfer stations.

Implemented 5 S and Lean to the production floor in order to have continuous flow with a complete new floor plan enabling point of use manufacturing.

Manufactured new camera conveyer, transfer, and return system prototypes for our outsource suppliers.

Trained production personnel on wiring and torque techniques when manufacturing all types of electrical/ mechanical sub-assemblies.

Integra Life Sciences (Formally Tyco Healthcare) Burlington, Ma. 2001–2014

Production Supervisor/Sr. Operations Engineering Technician

Transferred a multi-million dollar production facility consisting of over 30 products from our Massachusetts facility to the Boulder facility. This included fabricating duplicate fixtures, packing up remaining inventory, correcting documentation, filmed our entire manufacturing process and trained personnel.

Renovated and converted a warehouse into a Pilot Build Plant manufacturing environment designated to develop new products for Integra.

Supported the production floor generating ECO`s for all assemblies, routers, procedures, and specification sheets relating to all products including the Lighting, CRW, CUSA, and Software Products.

Implemented (MP2) Software a PM program essential in maintaining equipment used in the manufacturing of medical or commercial devices.

Designed the complete wire harness system for the NXT System, reworked PCB`s and introduced the first R & D Alpha & Beta units for the newly designed aspiration system.

Designed supervisory curriculum for the manufacturing build of our CUSA, OCS2, & PS2 production lines including complete CUSA aspiration tip testing.

Trained the Tullamore, Ireland facility on manufacturing & trouble shooting of the CUSA NXT after the system was transferred from the Burlington Plant.

Proficient in writing Protocols including IQ`s, OQ`s & PQ`s and Master Validation Plans.

Instrumental in the transfer of our newly acquired company Luxtec and Welch Allyn`s Lighting products which including BOM`s, creating routings, release of over 12K drawings.

Speedline, Ward Hill, Ma. 1999-2001

Manufacturing Engineer

Responsibilities included ISO auditing, generating wire lists, assembly procedures, production support, writing ECOs, AutoCAD 2000 and vendor liaison.

Converted the Gemini and 2800 systems into a Lean Manufacturing production line.

Completed System level testing of all product lines.

Managed, designed electrically, and implemented the flat panel monitor onto the Gemini system.

Created Operational Method Sheets for production and test applications.

Designed system cables and harnesses for the Gemini production line.

Implemented and trained manufacturing personnel to the Lean Manufacturing process.

Superior Design, Inc. Peabody, Ma. 1996-1999

Manufacturing Engineer/Purchasing Manager

Developed the next generation semiconductor ion implantation machine as liaison to Japanese joint venture engineering team start up R & D Operation.

Designed the de-ionized water-cooling system, vacuum and leak detection integration.

Monitored and integrated PCB, cable / harness and sub-assembly suppliers.

Procured $3M in inventory and implemented systems for bill of material costing product documentation, and inventory control.

Assembled PCB`s, electrical & mechanical sub-assemblies, including vacuum systems and final testing of the Ion Implanter.

Dynawave Corporation, Ward Hill, Ma. 1995-1996

Manufacturing Engineer/Production Supervisor

Supervised a two shift manufacturing operation of RF transmission cables for the NYNEX Cellular Phone network.

Managed all production schedules and training for a two shift operation.

Wrote necessary procedures needed to obtain the company`s ISO 9001 Certification.

Hired all production personnel for our 120 two shift operation; also managed and administered all performance appraisals.

Produced and developed all time standards and costs for each manufacturing assembly operation.

Analogic Medical Imaging, Peabody, Ma. 1993-1995

Manufacturing Engineer/ Production Supervisor

Directed a manufacturing team of 55 electro-mechanical, PCB and harness assemblers, including model shop technicians and responsible for sales of $15.5M per quarter.

Implemented improvements in procedures, policies and processes to bring operations into ISO 9001 compliance.

Developed zero defect teams to streamline production cycle times for the Siemens MRI systems.

Supervised & provided salary planning for five departments, which included 3 production areas, a proto-type shop, PCB rework and a cable department.

Varian/Extrion, (Currently Applied Materials) Gloucester, Ma.

Manufacturing Engineer

EDUCATION:

ASEE, Northeast Institute of Industrial Technology Boston, MA.

ASIE, North Shore Community College Beverly, MA.

Lean Certified University of Kentucky Mallinckrodt, Missouri

Blue Belt Certification Tyco Healthcare Burlington, Massachusetts

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