Senior Director of Systems and Test Engineering

• Jan 2020 - Present

Director of Mechanical and Systems Engineering

• Jun 2018 - Jan 2020

Sr. Manager

• May 2013 - May 2018

Hologic Developer of medical devices and products for the enhancement of women’s health. Sr. Manager, Systems Engineering May 2013-present Products Launched and Supported: Brevera-CorLumina Breast Biopsy System, Sapphire Breast Biopsy Consoles, Insight Mini C-Arm, Horizon & Latitude Bone Density Scanners, as well as Novasure and Myosure units. Direct management of multi-disciplined team of systems, compliance, software development, electrical, mechanical engineers as well as verification/validation personnel. Technical leadership of internal teams and external teams in the development and validation of medical systems. Responsible for ongoing identification of program risks, devising of contingency plans and execution of mitigations. Responsible for compliance strategies and attainment in support of Regulatory submissions and audits. Management of project forecast and budgets for financial reporting accuracy. Show less

Principal

• Jan 2013 - May 2013

Consulting Services for the Development of Medical Devices • Brainstorming and Concept Generation • Physician interviews for generation of requirements • Proof of Concept and Feasibility Models • Product Development, including: CAD Design and Detailing Prototyping and Assembly Performance Evaluation Stress-Strain Analysis (FEA) • DFM and Supplier Interactions through Pilot Manufacturing • Product Verification and Validation plans and execution • Bio/Skill and Pre-Clinical Evaluations • Project Management and Design Control for Medical Devices Show less

Sr. Director, Program Management Organization

• Dec 2011 - Jan 2013

Medrobotics: Developer of highly articulated robotic systems capable of minimally-invasive tortuous-path access and able to deliver a variety of surgical and interventional tools.•Responsible for planning, execution and control of projects in support of company goals.•Established team of project managers through hiring and development of internal personnel.•Provided constant visibility to critical path and actively modified execution strategy to optimize timelines.•Responsible for analysis of portfolio of projects, leading to adjustment in resource allocation and project prioritization. Show less

Director, Mechanical Engineering

• Jan 2009 - Dec 2011

Medrobotics: Developer of highly articulated robotic systems capable of minimally-invasive tortuous-path access and able to deliver a variety of surgical and interventional tools.•Launched Products: First generation, minimally invasive robotic surgical system for cardiac Clinical Study (Concept to Clinical study in 14 months).•Coordination of efforts of multi-disciplined team including specialists in Research and Development, Document Control, Quality, Procurement and Manufacturing.•Hands-on development and responsibility for mechanical design, including optimization of molded plastic and machined parts for function and manufacturability.•Responsible for design, development, and packaging of disposable system components; testing included biocompatibility, sterilization, shipping and aging.•Assembled and managed team of engineers, designers and consultants responsible for mechanical, electro-mechanical design, verification and validation of robotic platform. •Direct collaboration with clinical engineering and participation on numerous pre-clinical labs led to successful validation of requirements and effective product usability. •Coordinated and directly supported day to day activities, including proof of feasibility, definition of Inputs, and completion of Verification/Validation activities.•Guided activities of external vendors supporting industrial design and usability, electro-mechanical development, clean-room assembly process development, packaging, sterilization and safety testing.•Planned and coordinated logistics for support for clinical study in Europe, including safe transport, storage and post-shipment testing and set-up of clinical study articles in accordance to Clinical Protocol and Risk Management Plan.•Contributed to various patent submissions pending publication. Show less

Director of Engineering

• Oct 2008 - Dec 2008

IST: A spine technology company, developed motion preservation and minimally invasive treatments for spinal disorders.•Product Development: Axient Total (dynamic stabilization), Axient SC (semi-rigid fusion), consisting of complex posterior lumbar implants for coupled multi-axial motion in treated vertebral segments. •Designed multiple embodiments of pedicle screw based posterior spinal implants and instrument systems for semi-rigid fusion and dynamic stabilization.•Recruited, assembled and managed team of 8 engineers that supported research and development activities in Motion Group. •Worked with internal and external regulatory personnel to define testing and submission strategies for rigorous 510(k) and PMA processes. Established innovative test methods that enabled comparison to market leader predicate device.•Established test methods for system mechanical verification in internal and external servo-hydraulic test frames. Wrote protocols and reports, as well as conducted testing in support of FDA submissions. Authored portions of documentation for traditional 510(k) submissions.•Coordinated and conducted pre-clinical tests including 3, 6 and 12 mo ovine survival study, Cadaver range of motion studies (Loyola, John Hopkins, Toledo, RPI), and Surgeon Bioskills (cadaver implantation) studies for design development and validation of implants and surgical instrumentation.•Worked with IP group to write/review applications. Performed Freedom To Operate assessment to navigate through crowded IP space (Inventor in 1 patent and 9 published applications). Show less

Engineering Manager

• Sep 2006 - Oct 2008

See above under Director of Engineering, Innovative Spinal Technologies

Staff Engineer

• Sep 2005 - Sep 2006

See above under Director of Engineering, Innovative Spinal Technologies

Senior Engineer

• Jul 2004 - Aug 2005

BSC Oncology Division: Developer of interventional port, embolic and energy-based-ablation medical technologies for the treatment of oncological disease. •Launched Product: Soloist Single Needle Electrode; a disposable percutaneous radio frequency ablation wand for treatment of hard to reach tumors in liver, kidney and lungs. First year sales exceeded forecast and drove adoption of other products in line. •Conducted and directed research and development of energy based tumor ablation devices for the Oncology division. •Served as core team leader for Technical Development Process; overseeing pre-clinical, research and process engineering efforts. •Submitted various patent disclosures focusing on gaps in current portfolio and combination of energy based technology with emerging minimally invasive procedures. (Inventor in 2 Issued Patents and 5 Applications) Show less

Senior Design Engineer

• Feb 2000 - Jun 2004

Salient: Developer of electro-surgical products designed to assist surgeons during orthopaedic, spinal and surgical oncology procedures. •Launched Products: Sealing Hook SH2.0, Dissecting Sealer DS3.5C, Orthopedic Bipolar Sealer BPS5.0-VT. Research & Development: BPS6.0, ADP2.1, ADP3.2, and spinal scraper designs. •Technical leader and direct support of design, development, pilot manufacturing, verification/validation and launch of disposable surgical devices with controlled delivery of fluid (saline) and RF energy. •Generated multi-part mechanisms and engineering drawings with CAD. •Refined initial concepts from interaction with surgeon at office visits, OR cases and cadaver labs. Interfaced with members of Physician Advisory board to discuss needs and design options. •Responsible for supplier interaction in development of pilot components and application of Statistical Process Control in validation of parts. •Performed Finite Element investigation of coupled electro-thermal effect of RF energy on tissue, enabling the selection of materials and predicting thermal effect on tissue. •Worked in unison with patent attorney to identify design features for structure and method claims of patent applications. (Inventor in 7 Issued Patents and 9 Applications) Show less

Mechanical Engineer

• Jan 1999 - Jan 2000

Stationery Products Division: Manufacturer of Paper Mate, Parker and Waterman pens and writing instruments. • Launched Products: EraserMax, GelMax • Led mechanical design effort and supported manufacturing group for Stationery Products Division. • Used CAD to design injection molded consumer products for ultra-high volume PaperMate business. •Interfaced with Industrial Design and Marketing group to translate esthetic concepts into Pro/E. •Executed structural analysis of plastic components to aid in material selection process and for improvement of mechanical design; includes non-linear materials and contact FEA analysis. •Drafted by Advanced Research group to develop products for new competitive markets. •Led brainstorming, research and concept development effort leading to various design concepts submitted to company Intellectual Property attorneys. Show less

Design Engineer

• Jun 1996 - Dec 1998

JJPI: Developer of orthopaedic, spinal care, sports medicine and neuroscience devices for preservation of patient mobility. •Launched/Developed Products within PFC Sigma Knee System: (Asian Market Tibial trays, Bone Augmentation Components, Stem/Sleeve sintered stems, Rotating Platform system) •Generated multi-part functional prototypes (SLA and metal) for presentations of new concepts in nationwide conferences. •Defined optimal boundary conditions and validated FEA model of Ti Tibial Tray implant, leading to significant cost and time savings testing of subsequent products. •Worked with Applied Research group to develop and execute tests, interpret data, and generate reports for FDA submissions. •PATENTS:8 Issued by U.S. Patent and Trademark Office (USPTO); and European Patent Office Show less