Experience

• 

  Mammotome

  • Staff Systems Engineer
• 

  Devicor Medical Products, Inc.

  • Cincinnati, Ohio, United States

  • Staff Systems Engineer

    • Jun 2015 - Present
    • Cincinnati, Ohio, United States
• 

  Hill-Rom

  • Sr. Systems Design Engineer

    • Dec 2009 - Sep 2022

    Systems Lead of new development project, responsible for:- risk management (RA & DFMEA)- customer needs documents- system design requirements- test engineering (V&V)- regulatory approvals

• 

  Covidien

  • United States
  • Medical Equipment Manufacturing
  • 700 & Above Employee

  • Manager, R&D

    • 2008 - Sep 2009

    Responsible for sustaining engineering group, managing current and legacy product designs. Products include x-ray and magnetic resonance contrast power injectors, hydraulic positioning tables, nuclear medicine devices and sterilized plastic consumables. Accountable for engineering support of Manufacturing, QA/Regulatory, Marketing, Service and Clinical Applications functions. Position also charged with the technical aspects of OEM business relationships.• 45% improvement in system reliability of x-ray contrast power injector system by leading team through successful software & hardware upgrade project.• Investigated and resolved customer satisfaction issues with product designs (CAPA corrective & preventative actions, customer complaints, field service issues and clinical applications support).• Maintained FDA design control (DHF design history files, risk analysis, FMEA, customer & product requirements, trace matrices, verifications & validations, post launch assessments).• Developed custom power injector BOM’s with GE, Siemens and Philips.

  • Project Manager, R&D

    • 2003 - 2008

    Using Design for Six Sigma (DFSS) techniques, managed 5 new product development and manufacturing support projects. Directed cross-functional teams while holding total accountability for budget, schedule, risks, Voice of Customer research, global sales proformas, concept generation & selections, development of designs, global regulatory, verification & validations, manufacturing & service setup, sales training, launch and post-launch assessments.• Took over unclear and delayed magnetic resonance (MR) injector project, reorganized everything and then successfully led teams through global launches to gain 10% increase in sales.• Led crisis team to protect $100M business when a non-U.S. consumables factory was suddenly stopped. Qualified new suppliers, moved cells to alternate factory, design changes and cleared regulatory paths.• Managed nuclear medicine (NM) device opportunity project through research and concept stages, resulting in 45 detailed new product concepts, 12 of which were externally validated as have high market value.• Managed the first of new NM concepts, Technetium elution tool system, through successful launch.• Appointed to a select team to search and evaluate business partnership opportunities, which resulted in several collaborative arrangements.

• 

  Tyco Healthcare (now Covidien)

  • Principal Design Engineer

    • 2002 - 2003

    Performed as senior development engineer on both new product development and sustaining engineering issues, while providing leadership to growing R&D and Marketing departments. • Took over leadership of software upgrade project for power injector system. Project launched successfully and on...

• 

  Mallinckrodt (now Covidien)

  • Advanced Product Development Team Member

    • 1994 - 2002

    Appointed to cross-functional advanced product development core teams. Performed customer research, developed and prioritized customer & product requirements, brainstormed concept generations & selections, detailed design of electrical & mechanical assemblies, system verifications an...

• 

  Liebel-Flarsheim (now Covidien)

  • Manufacturing Engineer

    • 1991 - 1994

    Responsibility for manufacturing engineering and support of power injectors, Wire & Cabling department, x-ray film exposure products and customer repair department. Duties included department/cell layout, assembly processes, specifications, tooling, calibration methods, time standards, cost containment, quality requirements and training.• Designed first CT power injector production line, meeting all schedule, quality and productivity goals.• Initiated and executed capital equipment expenditures.

  • Process Engineer (electronic)

    • 1983 - 1991

    Responsible for creating assembly, calibration & test processes for electrical, mechanical and clean room consumable assemblies. Role included development of custom assembly and test equipment, creation & maintaining time standards, meeting annual cost reduction targets and implementation of engineering change orders.• Improved quality of Wiring & Cabling department by 90%. Received letter of commendation from production supervisor.• Designed manufacturing cell for 3 new x-ray film positioning products.• Successfully transferred-in and created manufacturing processes and cells for newly acquired power injector.• Transferred-out the Bovie electrosurgical product line to acquiring company.

• 

  Sybron Liebel-Flarsheim (now Covidien)

  • Electronic Techician

    • 1980 - 1983

    Performed calibration, troubleshooting and repair of x-ray contrast syringe power injectors, high voltage RF electrosurgical Bovie devices, hydraulically driven urological positioning tables and production test equipment & fixtures. Responsible for significant quality increase and 2X improve...