Medical Device Surgical

ANTHONY J. MARTINI

Ann Arbor, MI Phone: 816-***-****

https://www.linkedin.com/in/anthony-j-martini-34700527 Email: ***************@*****.***

Principal Engineer – Medical Systems

An accomplished professional with a comprehensive background as a medical surgical device inventor (30-page USA patent) & NPD systems engineer. Possesses a strong ability to lead NPD cross-functional teams (Electrical, Mechanical, Software, and Risk Management integration) in the requirements needed for complex medical device products.

An experienced engineer in medical compliance assessment, electromagnetic compatibility EMC/EMI design, product testing to applicable product standards and has completed global product certifications from the initial design concept through product launch. Consistently recognized by his peers as a Subject Matter Expert (SME) in areas of electrical safety certification, Electromagnetic Compatibility (EMC) design compliance, medical vacuum design, HMI integration, and automated process manufacturing. Has the sound technical knowledge needed to daedal the complete process of Cradle to Grave.

AREAS OF EXPERTISE

New Product Development

Medical Disposables

FDA 510(k) ASCA test plans

Notified Bodies (TUV, CSA, ETL)

Global Market National Differences

DIR MGT – Doors, Jama, Helix (SW)

NRTL Safety Certification Process

NRTL Service Contract Management

Product technical reviews

Global Product Sustainment

SME 60601-1:2020 (3.2 Ed)

Isolation Diagram creation

Critical Component (Clause 8.10)

IFU, Warnings, Labels & Symbols

PEMS, Clause 14 & 62304 Life Cycle

SDD & SVT requirements

Firmware, EMs & GUI (SW)

SME 60601-1-2:2020 EMC (4.1 Ed)

EMC (4th Ed) Test plan creation

SME ASTM D4169 Ship Containers

ISO 14971 Risk Management

ISO 13485 Quality System

CAPAs & NCMRs

SME 60601-1-8 Alarms

SME 62366 Usability/HMI

SME 60601-2-18 Endoscope

SME 60601-2-37 IVUS

SME 60825-1 Laser

Reach, RoHS, WEEE, Prop 65

SME 60601-1-11 Home Healthcare

CORE ACCOMPLISHMENTS

23 years of experience encompassing Research & Development (R&D), engineering design, defining compliance strategies for 60601-1 electrical safety & (EMC) iec60601-1-2 for medical product manufacturing.

Inventor U.S. Patent (US8827969B2) Sept 9, 2014 (See attachment).

Demonstrated success in managing domestic and global projects from inception to completion within time and budgetary constraints.

Successfully served as an NPD consultant on areas pertaining to product design, compliance assessment standards, integration, pre-certification testing.

Skilled in Special Manufacturing Processes involving fixture design, injection processes, thermoforming, tooling design, machine & tool processes, and pro/e solid model design.

PROFESSIONAL EXPERIENCE

TERUMO CARDIOVASCULAR / TERUMO HEART, INC. Ann Arbor, MI 2017 - Present

Division of Terumo Medical Corporation (Annual sales 10.7B)

Principal Engineer - Systems Department

Involved in the development and safety certification of the OpusWave (Dual Modality Cardiac Catheter Imaging system) used to identify the type, size & placement of cardiac stents and the correct deployment of the stent within the coronary arteries using a disposable electromechanical medical OCT/IVUS dual modality catheter (FDA Class 2 disposable).

Provided SME guidance to R&D teams & New Product Development.

SME over the Safety process design & NRTL’s point of contact.

Standard certification file directory created to allow NPD teams to access safety related information.

Managed all NRTL contracts, device testing and Medical Safety / EMC compliance.

Multiplatform development & Medical Electrical Certifications for the global sales market (28 countries).

Key Achievements:

SME IEC 60601-1:2020 (ED 3.2).

SME EMC IEC 60601-1-2:2020 (4th Ed) standard and 4.1 edition test plan author.

Catheter (FDA Class 2 Disposable design) with system testing for Global & NRTL certifications.

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

Earned recognition as an SME for evaluations of electrical safety / EMC pre-certification design testing.

STRYKER INSTRUMENTS, Kalamazoo, Michigan 2012-2017

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

Staff Compliance Engineer

Provided 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.

Direct the product certification process, ensure timely completion and certificate on time delivery.

NPD Global IEC/ISO standards assessments, REACH & RoHS 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).

Key Achievements:

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 & EMC certifications.

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

Created $288M in sales creating the innovative “Transposal Waste Disposal System” for surgical OR waste.

Staff Engineer / New Product Development Manager

Created a Surgical Medical System and other aspects of NPD for the company.

Medical Device/System multi sub-component design, proof of concept and medical product design.

Prototype to Design for Manufacture, SOP, QIP and Plant manufacturing process creation.

FDA point of contact for all interaction, CAPA’s, 510(k) and/or plant audits. Responsibilities also included all Federal regulations pertaining to the company or its employees.

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

Key Achievements:

Earned recognition as the inventor - “Transposal High Fluid Infectious Waste Disposal Cart System” protecting medical staff from exposure to bloodborne pathogens. The US Patent filed July 21, 2011.

Directed the concept development & managed the innovative design of a multi-cavity Class 1 injection mold for a medical disposable, achieving annual savings of $1.4M+ in the first year.

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

Illinois Licensed: Emergency Medical Technician/Ambulance Certification

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