Project Manager Medical Device
Resume:
**** ***** ***** **** ******* (Bill) Kuhns Phone: 925-***-****
Pleasanton, Ca 94566 *******@*******.***
Professional Objective: Expand my Project Manager Career skill set. Which currently includes the Medical Device industry, PM Automation Projects with ISO Quality Auditor & Assurance Compliance background.
Highlights and Qualifications:
Proactive hands-on problem solving.
Excellent interpersonal communications both written and verbal.
Goal oriented, creative, resourceful and proactive personality.
Proven effectiveness in coordination of team-oriented project management
Single point contact with Technical Engineering staff and Sciences community.
20+ years of Project Management experience, full project team community involved
Continue Project Management courses to stay current with trends.
Project Manager of 1 to 7 million dollar Solar Automation Manufacturing Projects
Experience with MRP. ERP. Software, SysPro and Arena as examples
Experience in authoring Project Acceptance Documentation
25+ years of experience in Design Control Process
Knowledge in Medical Device Quality System Regulations ISO 13485
Certified ISO-9001 Auditor, Site Quality Coordinator
Expert in 2D Anvil CAD design and layouts and detailing.
3D Solid Works experience in essentials BOMS and design updates.
Fluent in Microsoft applications: Word, Excel, Project, Power Point, Visio,
Employment History:
December 2017 – March 2019 Owens Design Inc.
Senior Engineer NPI
Manage New Product Introduction (NPI) of automation projects when required.
Updated deign details and customer changes to 3D Solid Works models when required
Incorporate design changes to on going automation builds upon customers request.
Customer contact along with using customer MRP to relay design changes along with ECO’s to current customer builds. Maintain Internal Issues lists.
Point of contact with fabrication vendors when requied.
Developed in-house Production Checklist to improve repeat build quality within Owens Design.
Introduction to ISO and internal 3rd party audit accountability for Manufacturing employees
Developed and issued internal ISO audits to ensure employees awareness of ISO compliance both 9001:2016 and 13485.
Solid Works classes completed Essentials of Solid Works
September 2009 – December 2017 ImmunoScience Inc. Pleasanton, Ca.
Project Manager, Automation Eng.
Responsible to select Automation Design Vendors to ensure functionality and delivery of Production Equipment to ImmunoScience Pleasanton Facility.
Oversee Design Automation groups in USA and India to ensure equipment acceptance.
Author Company‘s Operating Procedures and Validation Procedures for new automation and for ISO Compliance.
Authored Automation Factory Acceptance Testing and Sign off Approval documentation.
Traveled to India to monitor automation progress and acceptance criteria expectations.
Manage (hands on) Validation and Batch record runs of New Automation.
Develop vendor product relationships and improve product process, costing & availability.
Design and manufacture equipment tooling and fixtures to improve testing and production results of existing automation using Anvil Auto CAD 2d software.
Experienced with Vendor qualification process and on-site quality audits to ensure standards are met and maintained for ISO compliance.
September 2005 – December 2008 Xyratex Corporation Automation Group
Project Manager, Automation Division
Managed design team from equipment concept start to completion of production run of factory manufacturing automation.
Single point contact; build release of prototype equipment sent to overseas sister company.
Monitored Design changes and effected changes to BOM regarding Vendor communication.
Managed Front end automation project of all ILDS lines at Solyndra phase 1 factory.
Managed customer issues Meetings
In-house resident in Solyndra for 3 years to manage $ 7 million ILDS factory project.
August 1992 – September 2005 ATS Systems Inc. Livermore Ca.
Project Manager, Senior Designer, Automation Group
Managed design team from equipment concept start to completion of production run of factory manufacturing automation.
Single point contact; build release of prototype equipment translating into production machines
Monitored Design changes and effected changes to BOM regarding Vendor communication.
Established customer relationships during all project builds; managed customer Issues Meetings
Facility ISO 9001 Quality Coordinator 5 years.
Responsible for third party ISO certification audits, QMI.
Scheduled and carried out all internal ISO audits documented as required by ISO.
Authored Company ISO Quality Manual and internal department ISO procedures.
Senior Designer automation equipment development of design per customer requirements and expectations.
Generate BOMs and assembly drawings for system manuals and final documentation using Auto CAD Anvil 2D software
Seagate Magnetics - Senior Mechanical Designer R & D Division 1986 - 1992
Education:
Chabot Junior College, Hayward, California
PM extension classes SF. State California
USF Project Management Certified
QMI ISO 9001 Certified Auditor
USF Project Management Certified
Personal and Family interests:
Bay Area Native
Pleasanton, California resident, 26 years.
Married 30+ years, 2 children.
Additional personal references can be supplied upon request.
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