Product Development Engineer

ANTHONY J. MARTINI

Kalamazoo, MI ***** Phone: 816-***-****

Linkedin.com/in/anthony-martini-34700527 Email: *******************@*****.***

SR. PRODUCT DEVELOPMENT SYSTEMS ENGINEER & MANAGER

An accomplished, results-oriented and an innovative professional manager with a comprehensive background as an inventor. Technical daedal knowledge to process Cradle to Grave design applications. Proven expertise in New Product Development (NPD) and systems integration required for surgical equipment. Has strong leadership & mentoring abilities in leading cross-functional teams through the “Stage-Gate” development process while maintaining compliance from the initial design concept through product launch. Consistently recognized, by his peers, as a Subject Matter Expert (SME) in areas such as: fluid dynamics, vacuum design, HMI integration, electrical safety, industrial product design and automated process manufacturing. An experienced engineer in design validation, compliance testing, EMC/EMI design and assessment of applicable standards including hospital credentialed access.

AREAS OF EXPERTISE

New Product Development

Mechanical Engineering

Leadership & Teamwork

Global Market Safety Compliance

Lean Methodology

Design Engineering

Documentation & Reports

Project Management

Design for Manufacturing

System Engineering Principles

Automated Product Manufacturing

Communication Skills

Industrial Product Design

Product Safety/EMC Engineering

Regulatory Support

Domestic & Global Projects

Design Development

Injection Molding

Human Factors / Usability

Contract Service Management

ISO 13485 Quality System

ISO 14971 Risk Management

ISO/IEC 17025 Labs

RoHS, REACH, Prop 65

CORE ACCOMPLISHMENTS

32 years of experience encompassing the areas of Research & Development (R&D), engineering design, electrical safety and product manufacturing including 17 years in Medical Systems Design & NRTL Safety Certifications and 11+ years of experience applying Lean methodology in Process Improvement.

Inventor of U.S. Patent (US 2009/0101219 A1) awarded in April 2009.

Demonstrated success in managing both domestic and global projects through planning and problem solving.

Successfully served as an NPD consultant on areas pertaining to product design, compliance assessment standards, integration, specifications transfer and Critical Component identification.

Skilled in Special Manufacturing Processes involving 32mm systems, injection mold processes, machine & tool processes, thermoforming, tooling design and solid model drawing design management.

Conducted, through reviews of the market acceptance, launches of various NPD projects and platforms.

Microsoft Windows, Word, Office, Excel, PowerPoint, Access, Outlook, ACT!

PROFESSIONAL EXPERIENCE

STRYKER INSTRUMENTS, Kalamazoo, Michigan 2012-2016

$4 billion subsidiary of the $16 billion Stryker corporation, focused on medical instruments development.

Staff Compliance Engineer

Responsible for providing guidance to multiple R&D teams for concurrent New Product Development (NPD) projects

Drive the creation and execution of certification test plans, Nationally Recognized Testing Laboratory (NRTL) engagement activities and ISO 17025 lab test procedures.

Directed the product certification process, ensuring an on time safety certification and certificate.

NPD Global IEC/ISO standards assessments with compliance reviews of existing safety certificates.

Facilitate external contracts for services, including EMC/EMI performance and CB Certifications.

Provide audit and regulatory support for FDA, CSA, U/L, Intertek & TUV (Notified Bodies).

STRYKER INSTRUMENTS, MI (continued) staff Compliance Engineer

Key Achievements:

EU environmental programs REACH, RoHS, WEEE and Prop 65 for hazardous chemical reduction.

Earned recognition for providing SME on evaluations pertaining to electrical safety, pre-certification testing, design guidance, and device safety for both domestic and global projects.

Performed numerous evaluations of Medical Device/Systems for NRTL’s safety certifications.

DORNOCH MEDICAL SYSTEMS, INC., Riverside, Missouri 2001-2012

$88 million in sales creating the innovative “Transposal Safety Station” technology for surgical OR waste disposal.

Staff Engineer / New Product Development Manager

Responsible for creating a Medical Systems Device and other aspects of NPD for the company

Medical Device/System multi sub-component design, proof of concept, Industrial Product Design, Prototype to Design for Manufacture, SOP, QIP and Plant manufacturing process creation.

Integrated EMC / EMI design requirements and CDRH requirements.

Acquired FDA clearances and completed 510(k) exemption and 510(k) files for Class I/II MD classifications.

Ensured GMP compliance to 21 CFR 820 Quality System Regulation required for medical manufacturing.

FDA point of contact for CAPA’s, 510K’s, plant audits including regulations pertaining to its employees.

Facilitated the involvement of consulting engineering firms in all areas of development for software programming, mechanical drawings and electrical design.

Key Achievements:

Earned recognition as the inventor of the “Transposal High Fluid Infectious Waste Disposal Cart System” protecting medical staff from exposure to bloodborne pathogens. The US Patent awarded in April 2009.

Managed a project involving the design of a multi-cavity injection mold, achieving annual savings of $1.4M+.

Created a C-code based initiative to facilitate accurate equipment state identification, while reducing the cost of field service by 46%.

AMERICAN CATASTROPHE, INC., Kansas City, Missouri 1999-2001

$175 million commercial emergency disaster response and restoration company.

Consulting Engineer & Team Manager

Served as a HAZMAT team member responsible for utility electrical disconnection and on-site safety activities

Trained personnel in the disassembly and cleaning of damaged manufacturing equipment.

Acquired hands-on experience in the Desiccant and Lyophilization processes used in recovery efforts.

Key Achievements:

Designed a mobile electrical power system capable of providing power throughout the restoration process.

Created designs and fabrication plans to align with site dimensions for millwork and restoration contracts.

EDUCATION

Bachelor of Science in Industrial Engineering (BSIE), Emporia State University (Emporia, KS)

Associate of Business Administration, University of Missouri-Kansas City (Kansas City, MO)

PROFESSIONAL CERTIFICATIONS

CSA (NRTL) Certified SMT/CPC Stage 3 Lab Test Engineer

Intertek (NRTL) Certified Satellite Level 3 Lab Test Engineer

Certified IPC Specialist (no: 610MS-385-***-****))

U/L Certificate of Completion iec60601-1 (3.0 & 3.1 Ed) - U/L instructor training

HAZWOPER Certified (OSHA 29 CFR 1910.120) Respirator rating

Illinois Licensed: Emergency Medical Technician/Ambulance Certification

20170322

Contact this candidate