Engineer Manufacturing

Summary of Qualifications:

A ** year Medical Device Manufacturing Engineer and an expert with on-the floor manufacturing: SPC, MRB, ECOs, BOMs, labor standards, prototyping, facilities layout, personnel hiring, documentation and 16 years experience dealing directly with the FDA. Strong credentials as a Manager, Engineer and Supervisor. Comprehensive knowledge of requirement structures: ISO (9001:2008 and 13485:2003), 21 CFR part 820 (Canadian), IPC-A-610, ASTM, UL, GMP, MRP, JIT, ESD, QSR, FMEA, Lean Manufacturing, MTBF, FPY, Manufacturing Metrics and Validation Protocols (IQ, OQ & PQ).

Overview of Employment:

Byers Peak, Inc. (Contract Manufacturing – Medical Devices)

4975 Miller Street, Wheat Ridge, CO 80033: Manufacturing Engineer: MDC and RQA Administrator [4 yrs. 11 Mo.] October 2004 to September 2009

MDC (Master Documentation Center) Administrator: Reviewed all Receipts (literal count), Receiving Inspection CAPAs (Corrective and Preventative Action), DHR errors, and NCMRs (Non-Conforming Material Reports). Created databases and generated monthly internal and external (vendor and customer) QA trends. Processed, released and distributed all internal and external COs/ECOs/Permits and documents. Created, updated and tracked customer specific BOMs including out-of-house quotes for fabricated materials. Authored SOPs, DOPs and MOPs and controlled expirabable materials distribution databases pursuant to ISO standards. Trained and assisted project engineers in the writing, formatting and processing of permanent and Permit COs and Validation Protocols (IQ, OQ and PQ).

RQA (Receiving Quality Assurance) Administrator: Trained RQA personnel in the execution of QA inspections for in-process and finished assemblies and use of Receiving Inspection tools: Ring, Plug, Pin, Height and Thread Gages, Calipers, Optical Comparator. Executed over 1500 First Article Inspection Reports (FAIRs), wrote and/or updated over 2000 IPs (Inspection Plans).

Anderson Steel and Supply, Inc. (Steel Fabrication)

301 Orchard Lane, Billings, MT 59101: Manufacturing Engineer [7 mo.] September 2003 to March 2004

Scheduled jobs, oversaw processes and designed fabrication fixtures to optimize productivity and allow for quick turnaround of scheduled and non-scheduled (over-the-counter sales) for a structural steel fabrication company.

Position required training and on-the-floor use of all manufacturing processes for structural steel, sheet-metal, aluminum, plastics and composite materials. Became skilled in the use of: Band Saw (beams, tubular steel, angle and pipe), Brake, Shear, Welding, Railing, Paint (Primer, Base and Finish Coat), and Rebar (cutting and forming).

IGT (International Game Technology) / VLC (Video Lottery Consultants) / Anchor Gaming / Powerhouse Technologies (Gaming and Off-line Betting Terminals)

2311 South 7th Ave., Bozeman, MT 59715

Manufacturing Engineering Department Manager [2 yrs.], Manufacturing Engineer III [6 mo.], Manufacturing Engineer II [2.5 yrs.] August 1998 to May 2003

While Manufacturing Engineering Department Manager, the company secured a ~$40M contract [12,300+devices] under which my project leadership skills demonstrated our ability to provide accurate equipment, assembly and test documentation. Reconfigured manufacturing areas from ~32K+ sq. ft. to <17K sq. ft., saving company over $3000/mo. and allowing closure of an unneeded facility.

Using SPC quality and production analyses, wrote instructions for sub-assembly, final assembly, test and refurbishment and set labor standards on nine product lines encompassing 25 gaming machine configurations and 60+ separate sub-assemblies, inclusive of BOM management. Duties included communications with purchasing, vendors and engineering design staff to resolve problems.

Performed tolerance analyses on the use of a replacement O-ring, replacement setscrew; ‘D’ slotted rollers misalignment, power supply cover and optical sensors interference fits. Identified non-conforming parts and performed Validation Protocols. Designed a single cable harness to replace existing cable assemblies, which could be readily adapted to various jurisdictional requirements.

Gambro Healthcare / COBE Laboratories (Dialysis and Blood Component Technologies)

1185 Oak Street, Lakewood, CO 80215-4407; 1201 Oak Street, Lakewood, CO 80215-4498; Arvada, CO 80215

T18 Engineering Technician [1.75 yrs.] and T16 Lead Technician [7 yrs.], Supervisor [1.5 yrs.], T14 Test Technician [1 yr.] October 1987 to August 1998

As supervisor of 58 operators (three shifts), established labor standards for 10 circuit card assembly processes for 145 different circuit cards resulting in better placement of personnel, accurate allocation of cost to individual product lines and the elimination of five temporary personnel saving $135,000 per year.

As a member of the engineering team, designed, assembled and evaluated test equipment. Assisted operators in the troubleshooting and repair of automated insertion machines. Trained electronics technicians, circuit card rework/repair and test (ICT & bench) personnel in ESD (division-level trainer) and hand-soldering to IPC Classes 2 and 3. Initiated, researched, compiled and executed numerous Validation Protocols.

Given responsibility for ascertaining function of, and writing the test procedures for, four stand-alone circuit card testers used in a portable dialysis machine manufactured by a company acquired by Gambro Healthcare. The company was purchased in order to obtain the dialyzer (filter cartridge) and their Engineering department provided no documentation on the testing, design or function for any of their circuit boards or test equipment. Stand-alone testers and test fixtures were shipped to us loose in cardboard boxes with unattached covers to the extent that ~50% of the wire-wrap wires (all white) were broken within the testers. Bed-of-nails test fixtures required point-to-point continuity testing to create wiring diagrams and schematics for the ICT tester. These machines were used by the US Army in the Middle East (Desert Storm). The dialyzers could filter extremely muddy water to the extent that it was clean enough to use in a dialysis machine.

Provided test fixtures (ICT & bench) and test and assembly training to outside manufacturers’ personnel upon outsourcing of the Centry System 2 and Centry System 3 circuit card manufacturing. Process included writing procedural steps for performing product line specific traceability procedures. Created and documented lists of circuit board fixtures, schematics, test procedures, cabling and traceability processes.

Under ASTM packaging evaluation standards, redesigned the production and reusable shipping containers for the Centry System 3 dialysis machine. Created new drawings for containers (1 cardboard w/wood pallet, 1 all wood), shipping inserts and graphics. Wrote and executed 2 Validation Protocols on new containers, saving over $35K/yr.

Worked on Cx project (state of the art dialysis machine) from prototype, through manufacturing and into clinical trials.

AT&T / Western Electric (PBX Terminals)

120th Avenue & Huron Street, Westminster, CO

Grade 36 Manufacturing Technician [2.25 yrs.], Grade 34 Manufacturing Technician [1.5 yrs.] September 1983 to March 1987

Tested, troubleshot, repaired and refurbishing over 300 types of PBX system consoles for 'Console Shop' field repairs of PBX (Private Branch Exchange) telecommunications consoles.

Most test equipment used consisted of very large multi-rotary relay contacts, using patch panels and a punched tape reader with a 1000V breakdown test and ‘pixie tube’ numeric (step status) incandescent lamps. Tests were automated from breakdown to test completion unless a displayed failure occurred and required troubleshooting.

Upon having numerous noisy (buzzing) 911 consoles sent in to ‘Field Repairs,’ I made a suggestion that the inductors in the console circuitry be dipped in epoxy. Epoxy eliminated the noise. I received an award for the suggestion and the pre-manufacturing epoxy dip process was instituted for production.

Education:

Associate of Applied Science Degree in Electronics Technology: Denver Institute of Technology, 7350 North Broadway, Denver, Colorado 80221; Graduated May, 1983

References will be made available upon request.

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