Medical Device Engineer

BORIS DUBINSKY

617-***-**** ***********@*****.*** Newton, MA 02459

PROFESSIONAL SYNOPSIS

Demonstrated expertise in engineering, leading multi-disciplinary teams and guiding medical devices development from concept to production. Equally experienced in Mechanical, Electrical and Software Engineering domains. Strong record of leadership in Medical Device Quality Management System (QMS), Development, System Integration, Sensors, Product Requirements Specification, Verification and Validation, Test Methodologies, Regulatory Compliance, Project Management and Vendor Management

EXPERIENCE

Principal Quality Engineer – Contract position

Avedro Inc. Waltham, MA (2014 - present)

Providing Quality engineering services in design & development of ophthalmic Medical Device

Managing quality aspects of Design Controls to guarantee solid Design Verification traceability

Driving efforts to ensure that Design Requirements are verified & production release is validated

Reviewing and augmenting SOPs to enhance Design Control and Risk Management Processes

Responsible for Risk Management package development - Risk Plan, Analysis, FMEA and Report

Guiding & executing validation process (IQ/OQ/PQ) to transition combination Medical Device to production

Influencing device design ensuring quality in product requirements, testability and reliability

Providing product design adherence to ISO 13485, 14971, 21 CFR 820 and IEC 62304 & 62366

Authoring and implementing Engineering Change (ECO) & SOPs utilizing Arena PLM tool

Managing Design Requirements traceability & defects mitigation utilizing Test Track tool

Approving Electro-Mechanical designs & verification testing utilizing Solid Works & Altium tools

Medical Device Design Verification, Engineering Group Lead – Contract position

Heartware Inc. Framingham, MA (2012- 2014)

Design Verification Development for VAD (Electromechanical Heart Pump) & electronics peripherals

Managed a group of V&V engineers & techs generating objective evidence for verification

Defined project objectives and schedules, managed technical loads, budgets and resources

Drove design verification planning, execution and approval for clinical & commercial releases

Created test methodology (test cases) to verify system functional requirements (DIR, SRS, ERS)

Design of experiment: Analyzed system design to develop efficient tests methods that generate objective evidences of Verification that satisfy FDA & MDD approval acceptance criteria

Developed plans, protocols & reports, requirements traceability, verification tests, fixing defects

Lead weekly Cross-Functional defects analysis sessions to triage and define issues mitigation

Stimulated Cross-Functional Design Reviews and Risk Hazard Reviews to secure system compliance

Drove verification processes improvements towards tighter design control and risk management compliance to QSR, generated process defining documents (SOPs, Project Plans, Work Instructions)

Guided engineering through Regression Verification process caused by mid-stream design changes

Utilized Test Track ALM (App Lifecycle Mgmt) tool for verification consistency & traceability

Executed SW verification and integration process in compliance with MD SW standard - IEC 62304

Coordinated and reviewed Medical Device safety & efficacy testing per IEC 60601 standards

Worked in close cooperation with Regulatory Department to comply per ISO13485 & CFR 21.820

Systems Integration & Verification, Engineer Group Leader – Contract position

Instrumentation Laboratory, Bedford, MA (2010 - 2012)

Leading Integration & Verification development of in-vitro diagnostic blood analyzers

Defined project objectives and schedules, managed budgets and resources

Developed system functional requirements to achieve device clinical objectives and quality (tools utilized – DOORS, SAP)

Guided Hematology Analyzer Verification - optical, fluidics, throughput & thermal tests

Developed plans, protocols & reports to perform Verification tests & mitigating defects and issues

Contributed to Medical Device SW life cycle process implementation per IEC 62304 standard

Conducted Design (EE, ME, SW, PM & Quality) and Risk Hazard reviews (FMEA) per ISO 14971

Utilized statistical tools (Minitab) to define regulatory (FDA) sufficient yet practical Sample Size

Coordinated Systems group development efforts with other functional groups. ECO & CR generation (tools - SAP & IBM Rational Change)

Director of Engineering

Tekscan Inc, Boston, MA, (2004 -2009)

Leader of multi-disciplinary engineering team building sensor based devices from concept to production

Technical Management

Directed operations, assessed cross-disciplinary engineering team performance (mechanical, hardware and software engineers). Improved linearity characteristics developing lead resistance compensation circuit (patented). Defined product’s requirements. Co-authored patent. Led development of company’s first battery operated wireless (Wi-Fi: IEEE 802.11 and 802.15.4 protocols) system.

Technology Innovation

Defined product’s architecture design, integrating sensor electronics with software algorithms and UI. Transitioned MCAD to SolidWorks to gain seamless link of MCAD to EDA tools

Results Focus

Effectively managed engineering projects while growing company revenue from $9M to $15M and department from 6 to 10 engineers. Structured development environment enabling parallel development of multiple projects by setting goals and delegating measurable assignments. Established and guided rigorous Verification and Validation (V&V) process

Budget and Resources

Managed a $1.7M budget for implementation of engineering tools, licenses and personnel within engineering department. Conducted cost projections, budget management, and presented results to senior leadership team. Selected outsourced design house, managed and released new product as a result of $500K budgeted contract to develop system for pressure mapping apps

Business Development

Communicated technical vision and recommendations to senior management and cross-functions. Supported sales engagement with customers and trade shows promoting company products resulting in 10% increase of sales leads.

Process Improvement

Enhanced and maintained processes and GMP procedures per ISO 13485:2003 requirements. Guided medical device regulatory compliance of prototype testing per UL, CE IEC 60601-1 and FCC standards (EMI and safety) obtaining product certification in the first round of testing. Improved SW product definition and development process by introducing Agile review methods. Reduced SW project development and re-work time by 15%.

Project Manager - Cardiology Products

Philips/Agilent/Hewlett-Packard Medical Products, Andover, MA (1994 -2004)

Led multidisciplinary projects to generate documentation for 510(k) submission and FDA approval

Managed regulatory certification of Cardiology Info Systems with annual revenue worth of $7.2M

Performed EMI and safety certification test for medical devices compliance to IEC 60601 standard

Co-authored new cardiograph platform definition and specification selected for cardiograph to be developed and manufactured in Emerging Markets

Experience prior to 1994

Applications Engineer & IC Semiconductors Product Development Engineer

Analog Devices Inc, Wilmington, MA, (1989-1994)

Education

Boston University, Boston, MA BSEE & MSEE – concentration – IC electronics

Moscow University, Moscow, RU BSME - concentration in electro-mechanical design

Northeastern University, Boston, MA MBA, High-Tech – engineering management

Computer Skills: Altium, OrCad, C, VB, Solid Works, Test Track, Agile, Minitab, SAP, DOORS, IBM Rational Change

Patents:

1.Control circuit for sensor array and related methods (Pub. No.:

US 2007/0234825 & US 2007/023521)

2.Heater Unit humidification chamber monitor

(USPTO Application #: 201******** – Class 261128)

International Experience Managed global development teams in Germany, India and China

Personal US Citizen

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