Engineer Sales

William R. Martin

Lake Forest, CA *****

949-***-**** ( *************@***.***

Mechanical Engineer with 30 years experience with medical device companies

and 19 years experience in leadership and management positions. Expertise

in engineering, operations, document control and facilities management of

medical device companies. Extensive product development, manufacturing

engineering and process development engineering experience of medical

devices. Exceptional knowledge of FDA, QSR and ISO 13485 regulatory

requirements along with ISO 9001 expertise. Mentor to engineering

personnel, manufacturing personnel, document control personnel, operations

personnel and facilities personnel.

Key competencies:

Product Development Process Lean Manufacturing / Six Sigma

Project Management Cross-Functional Leadership

Facilities Management Negotiation Techniques

Strong analytical and problems solving Equipment & Process Validation

skills Design for Manufacture (DFM)

Process Capability, SPC, DOE AutoCAD / SolidWorks

Fixture & Tool Design

PROFESSIONAL EXPERIENCE

Spectrum Laboratories, Inc. Rancho Dominguez, CA 2002 - 2010

A manufacturer of membrane filtration products for the medical, laboratory

and pharmaceutical markets.

Principal Engineer

. Improved sales by 12% by implementing a proprietary spinning machine for

the production of hollow fiber membranes. Next 10 years of company

growth is projected to come from this spinning machine.

. Implemented a water integrity test process that saved the company

$240,000 annually of direct expenses while improving quality and reducing

direct labor using Six Sigma techniques.

. Installed new electrical main, reverse osmosis water system, clean dry

oil-less air source to support new semi-automated PLC controlled

equipment while staying within budget and time projections.

. Increased sales 10% per year by meeting 5 consecutive years of corporate

product development goals of launching new products into the

pharmaceutical filtration markets using aggressive project management and

design controls principals.

. Directly performed or oversaw the validation of all equipment implemented

in the last eight years.

VP Manufacturing

. Responsible for operations department, engineering department, document

control department and facilities.

. Reduced backorders by 85% by streamlining manufacturing processes and

improving work order and planning process.

. Improved on time shipping to domestic and international customers by 60%

by implementing production planning process and creating custom reports

to improve visibility.

. Reduced equipment down time by 24% by using a risk based approach to

facility maintenance.

. Management representative for ISO quality system.

Engineering Manager

. Mentor and coach engineers and junior team members from Quality,

Operations, Engineering, Document Control and Facilities. Multiple

employees were promoted into new higher level positions - including Sr.

Project Engineer and Quality Control Manager.

. Implemented process validations, assembly/test equipment development &

validations (IQ/OQ/PQ), component change validations and conducted

assembly FMEA analysis. Process changed from a corporate weakness to a

corporate strength measured by customer audits.

ENDOCARE, INC. Irvine, CA 1999 - 2002

A developer, manufacturing and marketer of cryo-surgical products.

Director of Operations

. Managed operations through eight consecutive quarter sales growth of 20%

per quarter and was directly responsible for operations while taking the

company from 2 million in sales to 15 million in sales.

. Achieved every corporate shipment target while in the role.

. Managed a cross-functional team from Sanarus Medical (sister company) in

the development and manufacturing scale-up of the VisicaTM cryoablation

probe and the CentricaTM biopsy probe and system for breast cancer

patients.

. Represented, along with QA/RA Director, two FDA audits that yielded no

observations.

. Responsible for planning a corporate move from a 16,000 sq.ft. building

to a 28,000 sq.ft. building including a Class 10,000 clean room as one of

its requirements.

. Implemented manufacturing cells for disposable assemblies enhancing

production rates by 18% while improving quality on all disposables.

Manufacturing Engineer

. Transferred from design to manufacturing, new cryoablation system, three

new ablation probes, and a family of prostate stents.

. Managed product introductions from prototype build through design

transfer. Reviewed product designs for manufacturability (DFM).

Designed production fixtures, developed manufacturing processes, analyzed

process capability and documented all per ISO guidelines and corporate

procedures.

. Managed and executed design and process validations, equipment

optimization, and material qualifications. Evaluated in-process failures

& field complaints, determined root cause, implemented corrective

actions.

. Designed new cryo-stat winding fixture that improved cryo-probe

consistency and reduced cryo-probe failure rate by 32%.

CONTINUING EDUCATION

SolidWorks 2006, Hawk Ridge

Negotiation Techniques, American Management Association

Time Management, American Management Association

Supply Chain Management, Certificate, University of California Irvine

Project Management for Technical Professionals, Certificate, University of

California Irvine

PLC Fundamentals, Basics, Intermediate, & Advanced, Allen-Bradley

Auto Cad Design Applications (Level I & II), Hennepin County Technical

College

Machine Shop, Level I, Hennepin County Technical College

Electronics Technician Program, Northwestern Electronics Institute

ACADEMIC BACKGROUND

Mechanical Design Technology, Associates Degree, Minnesota Riverland

Technical College

COMPUTER SKILLS

Microsoft Suite (Word, Excel, PowerPoint, MS Project), AutoCAD, SolidWorks,

Photoshop CS4, Visio, MIS systems including MAPICS, Minx, MAS 90.

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