PROFILE:

• Senior Project Engineer, Manufacturing EngineerSenior Manufacturing Engineer, Molding Manager, Vice President, Plant Manager and Director of Operations in polymer/metal manufacturing businesses.
• Over 30 years in business development and recognized for Plant and Operations management.
• More than 15 years experience in medical devices and experienced in manufacturing plants in Mexico.
• Experienced in directing/coordinating many plant activities: Maintenance; Manufacturing: molding, extrusion packaging, distribution and assembly (LEAN Manufacturing)
• Machine shop & tool room; Quality AssuranceISO 13485 experience, GMP’s; Plant safety; Plant training programs; Plant and production line layout
• Assembly and automation; Many engineering responsibilities;
• Experienced in capital projects departmental budgeting and P&L responsibility; good at identifying & developing talent; US patent experience.

CAREER HISTORY:

Confidential, Irvine, CA

Sr. Manufacturing Engineering Lead (Project Manager)

Responsibilities:

• Worked on re - starting and requalifying (DVT & Process) Micro Catheter at Reverse Medical and worked on Tech Transfer team to transfer the product to the Irvine Confidential site.
• Equipment was paced in storage and Micro Catheter product retired when Confidential purchased Reverse Medical.
• Worked with Quality Lead to build and qualify an ISO Class 7 CER (class 10,000).
• Authored qualification and test report to re-IQ all the retired equipment.
• Executed three PPQ lots and built over 1,000 Micro Catheters.
• Was Technical Engineer on tech transfer team and reviewed and provided feedback on all drawings, Manufacturing process instructions, Quality Inspection procedures, and worked with Design Team on Device Master File improvements including all risk documents.

Confidential, So. San Francisco, CA

Sr. Technical Manager

Responsibilities:

• Working on a Combination Product paired with a drug product for Ocular Implant to help treat Macular Degeneration. (Phase II Clinical Combination Product)
• Coordinated GMP Commissioning and closure of CAPA’s and Audit/Report with Contract Manufacturer (CMO).
• Worked with CMO & Confidential to close DHF gaps through including missing documents.
• Contributed to and supported design Verification & Validation activities including protocols, testing & test reports.
• Assisted in the updates of FMEA’s per ISO 14971. (pFMEA w/CMO; dFMEA, uFMEA & sFMEA w/ Confidential )

Confidential, San Jose, CA

Sr. Quality Engineer

Responsibilities:

• Involved in supplier qualifications for new Thrombosis Catheters and CAPA for non-conforming materials from suppliers.
• Authored and executed 7, Supplier Master Validation Plans 11 different parts. Coordinated and supported supplier’s protocols and test reports for components used in a new Medical Device.
• Coordinated and closed Corrective & Preventative Action with (22 NCMR’s) non-conforming materials with suppliers.

Confidential, Draper, UT

Manufacturing Engineer

Responsibilities:

• Involved in the day to day support of RF Sealing equipment & Blood Shakers and weighing equipment.
• Sebra equipment line.
• Responsible for validating new OEM equipment supplier. (Supervised 3 production workers)
• Executed and authored 15, protocols & test reports in support of Sebra production.
• Processed over 70 Engineering Change Orders to correct documentation and include RoHS compliant components.
• Completed investigation, corrective actions and closed two CAPA’s originating from documentation issues.

Confidential, Kalamazoo, MI

Supplier Quality Engineer

Responsibilities:

• Involved in performing supplier audits and helping to bring suppliers up to FDA 21 CFR 820 requirements.
• Responsible for developing validations and test reports for fixtures/equipment in both internal Stryker and remediation with suppliers.
• Audited on average 2 suppliers per month to FDA and ISO 13485 requirements.
• Authored three validations and test reports for fixtures and provide evidence that the fixtures performed as designed.
• Assured all documentation; drawings, work instructions were up to date and in place. Authored risk documentation.
• Solved a float sinking problem on the Neptune Waste Management product.
• Eliminated the glass in the plastic and improved the spin welding process.

Confidential, CA

Manufacturing Engineer

Responsibilities:

• Involved in custom equipment to make medical devices and tooling for those devices.
• Responsible for processtraining documentation, and process improvements in the machine shop and tool room.
• Assisted in supervising 10 hourly workers
• Shortened tooling lead times from over 10 weeks to less than 3 weeks, while increasing tooling through put by three times.
• Also made many quality improvements, while maintaining the same headcount.
• These goals were accomplished through utilization of Visual Manufacturing, LEAN techniques & implementing a Kanban inventory for tooling components.
• Participated in the qualification of and development of suppliers and vendors for ISO/FDA medical device manufacturing.

Confidential, Carlsbad, CA

Molding Manager

Responsibilities:

• Involved in custom contract manufacturing and custom injection molding of medical devices including implantables and other plastic products.
• Responsible for the day to day operations in molding and assembly.
• Managed 4 supervisors, 1 engineer and 124 hourly workers; $ 12 million in sales.
• Improved ISO/GMP compliance through training and documentation while growing in productivity 70%.
• Improved overall plant safety and reduced worker compensation multiplier.
• Reduced manufacturing lead times from 8 to 10 weeks, down to 2 to 4 weeks.

Confidential, Hemet, CA

Owner

Responsibilities:

• Involved in material selection, polymer chemistry, plastic processing, plant automation and mold design recommendations, for medical devices and consumer products. Developed new business feasibility studies and basic business plans.