Engineer Project Manager

Location:

Hamden, CT

Posted:

August 09, 2014

Contact this candidate

Resume:

Henry E Holsten

** ******** ******, ******, ** **518

*****.*******@*****.***

Home: 475-***-****

Cell: 203-***-****

QUALIFICATION PROFILE

Results-oriented, self-motivated Staff Engineer with a strong background in Design, Manufacturing Engineering

and Electronics focused on Technology Growth, Research and Development, process improvement and design

projects within the medical device industry. Years of experience encompassing design, test, rapid prototyping,

vendor development, pilot production and manufacturing. Strengths include strong leadership, mentoring and

analytical skills with the ability to communicate comfortably with all elements and levels in a medical device

manufacturing organization. Skills include Solidworks, Pro E Creo, Minitab, DFSS, Agile, project

management, and problem solving.

CORE COMPETENCIES:

Innovation: Developed and brought to production: Process: Manufacturing Processes:

VCS clips Metal Stamping

Endo Paddle Retract Molding

Protack MIM

Endo GIA Universal Sintering

PCEEA SLA

TA Sterilization

Align Packaging

Avaulta DMLS

Ajust. Ajust Helical Sewing

Fixt

Surgical: Types of surgeries attended: Clinical: Knowledge in the following clinical areas:

Bariatric GI Tract

Splenectomy Bariatric

Pelvic Floor Reconstruction Hernia

Pelvic Anatomy

Materials: Some materials used during designing: Coatings: Experience with the following coatings:

Implant grade steels Medcoat 2000

Degradable Polymers Nickel Teflon

Polycarbonate PTFE Coating

ABS Anodize

HST (Heat Shrink Tubes) Hard chromium

Project Leader: Lead role in the following: Design Tools and Software; Experience with the following:

Pro E (familiar)

Pilot production and design EGIA Universal Solidworks

Transfer Protack to Manufacturing Lightyear (SLA)

Initial Pilot Room Start up DFSS

Align and Avaulta Pilot Manufacturing Process Validation

Design and Development of Ajust, Nuvia SI and Fixt SAP

Project Manager/Lead Endo Catch Revitalization Qumas

AGILE

Management skills:

Managed Georgia Tech Co-op Program for division

Managed direct and indirect reports

Responsible for Performance Evaluations

Budgets for Capital Expense Projects

Accountable for Project timelines and Deliverables

PROFESSIONAL EXPERIENCE

Covidien

North Haven, Ct

Position: Staff Development Engineer/ Team Leader/Project Manager May 2012 to present

• Interfaced with Contract Manufacturers to commercialize projects

• Collaborated with international and domestic clinicians to vet out new product concepts/designs

• Design Stage Review Auditor

• Project lead/manager for Endo Catch Revitalization

• Responsible for leading and mentoring of direct reports and extended cross-functional team

• Created and maintained expense and capital budget

• Project technical lead

• Multiple invention disclosures for new specimen bag and trocar seal

• Assumed a designer role to aid in product development efforts

CR Bard Oct 2008 to May 2012

Covington, GA

Position: Lead Development (Staff) Engineer

• Designed/Developed Ajust™ resulting in 8.5 million dollars in incremental revenue first year domestic

• Developed processes for Avaulta™ a project which grossed over 20 million dollars revenue first year

• Created and commercialized Fixt™ Introducer

• Authored component / product qualifications in preparation of FDA submission

• Design Council Facilitator

• Supervised / Mentor design team personnel and other staff in support of project goals.

• Lead technical development activities for research and development projects, including product conceptualization, design

development, supplier identification and selection, managing vendor activities and developing manufacturing processes.

• Identified and documented all design, product, tooling and process specifications.

• Developed new and novel solutions for design and product enhancements.

• Submitted and review intellectual property for new innovative solutions

• Interacted with Clinicians during product concept design and development in office and clinical environments.

CR Bard June 2006 to Oct 2008

Covington, GA

Position: Project Engineer

• Responsible for new product discovery, and research, including, timeline development and leadership of team members.

• Involved in multidiscipline responsibilities including, product design, molding, assembly and biomedical technology.

• Lead IQ, OQ, PQ activities for new equipment and processes

• Served as a creative and technical resource to division and other business units.

• Interfaced with a wide variety of specialty disciplines, including physicians and clinicians, suppliers, consultants, and other

divisions within the corporation.

US Surgical, Tyco Healthcare, Covidien 1993 to June 2006

North Haven, CT

Position: Senior Development Engineer

• Developer of Covidien Tri-Staple™ concept resulting in over 2 billion dollars in incremental NPD revenue

• Product Design, Development and Commercialization of emerging Laparoscopic and open surgical products

• Performed FMEA’s for application, design, and production

• Functioned as a liaison between departments to manage quick and effective product development, qualification and

launch

• Championed Transfer of products from pilot/development to manufacturing

• Utilized DFSS to ensure robust product design

• Worked with teams during brainstorming sessions to develop products for GIA, Hernia, Thoracic and other applications.

• Experienced with the following processes: Process and Product Validations & Qualifications, Test Method Validations,

Installation and Operational Qualifications.

• Drove Rapid Prototyping of New Concepts

• Performed Design Reviews for new products

• Created Test Protocols for new concepts

Position: Development Engineer

• Responsible for supporting production requirements for pilot manufacturing lines

• Created and manufacturing processes, test methods, and production lines, while ensuring compliance to SOP’s and

GMP’s.

• Participated in various cross-functional teams to improve process & productivity goals

• Maintained Product Manufacturing Metrics

• Developed Test Methods for Quality Standards, Test Equipment (i.e. Leak Testers and Burst Testers)

• Supervised Engineering Technicians and Pilot Line group leader during product development and qualification

• Trained and certify associates to manufacturing processes and Quality Standards

Hamilton Sundstrand, UTC 1985-1993

Windsor Locks, Ct

Position: Sales Quality Control

• Developed corrective action plans to preclude recurrences of discrepancies relating to product assembly and quality

• Responsible for assembly and quality of electronics from component level through finished product

• Interfaced with customers on issues pertaining to product integrity, construction and quality

US Navy 1979-1985

Position: Electronic Technician/Reactor Operator

• Accountable for operation, calibration, maintenance, and repair of electronic equipment vital to ships operation

• Modified and repaired electronics to military standards

• Trained and certified subordinate personnel to operate and maintain equipment and systems

• Maintained records for equipment maintenance and employee training/qualification

EDUCATION

United States Surgical /Tyco Healthcare, North Haven/Norwalk Ct.

Statistical Process Control, Effective Communication, Pro Engineer (Basic Part, Basic Drawing), SAP, Interlink, New Manager

Hamilton Sundstrand, Windsor Locks Ct.

Introduction and Advanced C Programming, Effective Communication, Conflict Management, Continuous Improvement

Naval Nuclear Power School, Orlando, Fla.

Naval Electronics Technical School, Great Lakes, Ill.

Electronic Theory

Windsor Locks High School, Windsor Locks, CT.

Central State University, New Britain, CT.

UConn, West Hartford, CT. various engineering courses

HONORS/AWARDS

Awards:

2009 Bard New Product Development Individual contributor

2010 MDEA (Medical Design Excellence Award) Ajust

2010 Bard Leadership Award

2011 ESP (Excellence in Surgical Products) Fixt

2013 Covidien Tri-Staple - 1 billion dollars new revenue growth

Patents

Patent #5,803,902: Surgical retractor

Patent #5,830,221: Coil fastener applier

Patent #7,398,908: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #7,401,721: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #7,407,075: Staple cartridge having multiple staple sizes for a surgical stapling instrument

Patent #7,455,676: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #7,464,847: Surgical stapler with timer and feedback display

Patent #7,472,816: Stapling instruments including a cartridge having multiple staple sizes

Patent #7,481,349: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #7,588,174: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #7,666,180:Gastric restrictor assembly and method of use

Patent #7,722,610: Multiple coil staple and staple applier

Patent #7,726,538: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #7,726,539: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #7,828,189: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #7,837,079: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #7,837,081: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #7,845,534: Surgical stapler with timer and feedback display

Patent #7,870,989: Surgical stapler with timer and feedback display

Patent #7,891,534: Surgical stapling device

Patent #7,934,628: Surgical stapling device

Patent #8,033,440: Surgical stapling device

Patent #8,052,024: Surgical stapler with timer and feedback display

Patent #8,070,035: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #8,113,406: Surgical stapling instruments including a cartridge having multiple staple sizes

Patent #8,113,407: Surgical stapling instruments including a cartridge having multiple staples sizes

Patent #8,113,408: Surgical stapling device

Patent #8,114,010 Gastric restrictor assembly and method of use

Patent #8,123,100 Surgical stapling instruments including a cartridge having multiple staples sizes

Patent #8,123,705 Surgical stapler with timer and feedback display

Patent #8,157,150 Surgical stapler with timer and feedback display

Patent #8,157,152 Surgical stapling instruments including a cartridge having multiple staples sizes

• Patent #8,206,280 Adjustable tissue support member

• Patent #8,272,552 Surgical stapling instruments including a cartridge having multiple staple sizes

• Patent #8,281,973 Surgical stapling device

• Patent #8,286,848 Surgical stapling device

• Patent #8,292,146 Surgical stapling instruments including a cartridge having multiple staple sizes

• Patent #8,348,972 Surgical staple with augmented compression area

• Patent #8.381,961 Surgical staple including staple with plate

• Patent #8.382,761 Surgical stapling apparatus width adjustable width back span

• Patent #8,418,904 Surgical stapling device

• Patent #8,505,802 Surgical stapler with timer and feedback display

• Patent #8,529,599 Tissue tension detection system

• Patent #8,547,149 Adjustable tissue support member

• Patent #8,579,178 Surgical stapling instruments including a cartridge having multiple staple sizes

• Patent #8,608,047 Surgical stapling instruments including a cartridge having multiple staple sizes

Patent Applications:

• +200******** Coil fastener applier and removal method

• 200******** Surgical stapling device

• 200******** Gastric restrictor assembly and method of use

• 200******** Tissue tension detection system

• 200******** Multiple coil staple and staple applier

• 200******** Surgical stapler with timer and feedback display

• 200******** Surgical stapling instruments including a cartridge having multiple staple sizes

• 200******** Transdermal magnetic coupling gastric banding

• 200******** Surgical stapling instruments including a cartridge having multiple staple sizes

• 200******** Surgical stapler with timer and feedback display

• 200******** Surgical stapling instruments including a cartridge having multiple staple sizes

• 200******** Surgical stapling device

• 200******** Surgical stapler with timer and feedback display

• 200******** Surgical stapler with augmented compression area

• 200******** Surgical Stapling Instruments including a Cartridge Having Multiple Staples Sizes

• 200******** Surgical Stapling Instruments including a Cartridge Having Multiple Staple Sizes

• 200******** Surgical staple with adjustable width back span

• 200******** Adjustable tissue support member

• 200******** Surgical Stapling Instruments including a Cartridge Having Multiple Staple Sizes

• 200******** Surgical stapling device

• 200******** Surgical Stapling Instruments including a Cartridge Having Multiple Staple Sizes

• 201******** Surgical stapler with timer and feedback display