Engineer Design

Hugh Hestad

**** ****** ****** *****

Edina, MN 55410

952-***-****

EXPERIENCE

Zimmer Spine 2003-present, Senior-II Development Engineer, R&D

. Project Lead for line extension projects as well as new platform

products.

. Managed cross functional product development teams.

. Evaluated and developed intellectual property for new product

ideas.

. 40 patent applications

. 5 issued US patents

. Participated in product development system improvement committee.

. Created and lead innovation forum.

St Jude Medical, Daig Division 1999 - 2003, Senior Design Engineer,

R&D Electrophysiology

. Lead projects for Electrophysiology catheter products from concept

through launch, new platform products as well as platform iteration

products.

. Design of diagnostic and therapeutic intravascular devices.

. Managed development of new processes to meet design requirements.

. Lead multi-departmental functional teams to transition from

development to production.

. Develop performance criteria, test methods, quality requirements

and documentation to support internal and external documentation

requirements.

. Determine regulatory requirements, and prepare required documents

for FDA 510(k), and PMA submissions.

. Lead team efforts to establish timelines for resources required to

complete projects on a timely basis.

. Develop protocols and manage animal studies to evaluate preliminary

product design.

Scimed Life Systems 1997 - 1999, Senior Design Engineer, R&D Cardiology

Catheters

. Development of technology for cardiology guiding and diagnostic

devices from concept into production.

. Design of cardiology intravascular devices.

. Lead multi-departmental functional teams to transition from

development to production.

. Develop performance criteria, test methods, quality requirements

and documentation to support internal and external documentation

requirements.

. Determine regulatory requirements, and prepare required documents

for FDA 510(k), and PMA submissions.

. Lead team efforts to establish timelines for resources required to

complete projects on a timely basis.

. Develop protocols and manage animal studies to evaluate preliminary

product design.

Mentor Corporation 1995 -1997, Design Engineer, R&D Surgical

Development Group.

. Development of implantable devices for Urology.

. Established test criteria, designed and qualified test equipment.

. Completed retrospective design validation for existing implant.

. Developed biomaterials library.

Dacomed Corporation 1990 - 1995, Project Engineer, Product Development

. Responsible for continuation engineering of 6 urological medical

products including diagnostic and implantable devices.

. Supervised product development technicians, design machinist and

draftsman.

. Supervised engineering documentation.

. Successfully redesigned implantable penile prosthesis increase

reliability and eliminate failure modes.

. Co-developed ambulatory urethral pressure monitoring device in

conjunction with Israeli company and successfully to human trials.

. Established product development documentation to meet QSR/ISO 9000.

Graphic Specialties 1984 - 1990 Fabrication/Machine Shop Supervisor

. Supervised machinists, fabricators, assembly and installation

personnel.

. Developed processes for milling, routing, spraying and cutting

operations.

. Developed designs for construction of architectural signs and

structures.

PROFESSIONAL SKILLS

. Excellent written verbal and written communication skills in

dealing with technical and non-technical people internally and

externally

. Skilled in project management using Microsoft project and other

methods

. Experienced in designing and analyzing mechanical components using

CAD

. Experienced in prototyping components and assemblies using

machining, molding and other processes

. Knowledgeable in production processes involving injection molding,

machining, extrusion, bonding, laser welding, as well as other

processes

. Broad knowledge of biomaterials including thermoplastics, silicones

and metals

. Experienced in establishing test methods and designing test

equipment for mechanical and electrical testing

. Knowledgeable in GMP, ISO, ASTM and ANSI standards.

. Familiar with QSR/ISO 9000 requirements

. Experienced in working with Lean sigma, Kaizan principles

EDUCATION

University of St. Thomas

Currently perusing an MS in Technology Management

University of Minnesota

Coursework toward MS in Biomedical Engineering

Biomaterials, Anatomy and Physiology

St, Cloud State University

BS Industrial Engineering - 1990

Emphasis in Mechanical Design

Vermillion Community College

AAS Water Technology - 1982

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