Tom Spear

Tom Spear Email and Phone Number

Senior Engineering Project Manager, R&D Engineering, Healthcare, Disinfection Systems
Tom Spear's Location
Greater Cleveland, United States, United States
Tom Spear's Contact Details

Tom Spear personal email

n/a
About Tom Spear

Practical Management Experience• Over 20 years in the medical device industry in different roles with both large and small companies. Extensive background in product marketing, product development and product launch. • Working knowledge of medical device regulatory & applicable FDA standards, including:− CFR 21 Parts 820/11, ISO 13485 (quality systems management)− ANSI/AAMI/ISO 14971 (risk management)− ANSI/AAMI HE75 (human factors)− ANSI/AAMI/IEC 62366 (usability engineering)− ANSI/AAMI/IEC 62304 (medical device software)− ANSI/AAMI/IEC 60601 and 61010 (medical electronic equip.)− 93/42/EEC European Council Directive for product CE-marking • Proficient at lean product development techniques, including:− Defining/translating product design requirements− Specification writing− Verification/validation testing and traceability− Defect tracking• Establishing project planning and metrics− Operating and capital budgets, including prototype depreciation schedules− Detailed schedules, including task dependencies, critical paths and resource allocation• Success in leading multiple cross-functional teams for developing and sustaining profitable product lines − Led numerous projects ranging from new product development to sustaining engineering efforts with endoscopic, percutaneous and implantable instruments− Understand engineering processes and tools and organizational dynamics in Fortune 500 as well as smaller niche companies − Experience in product reliability testing, usability validation, risk management techniques and root cause problem solving techniquesInterpersonal Skills & Leadership Qualities• Demonstrated ability to mentor and motivate engineers to focus on critical tasks and meet project objectives. Have built strong working teams with clearly defined roles and responsibilities while managing both inexperienced and seasoned engineering professionals.• Fact-driven, results-oriented and quality-conscious. Adept technical writer.

Tom Spear's Current Company Details

Senior Engineering Project Manager, R&D Engineering, Healthcare, Disinfection Systems
Tom Spear Work Experience Details
  • Steris Corporation
    Senior Engineering Project Manager, R&D Engineering, Healthcare, Disinfection Systems
    Steris Corporation 2014 - 2016
    Mentor, Oh, Us
    • Led team of systems, mechanical, software and test engineers in development of a high level disinfection endoscope processing system per FDA guidance for automated endoscope reprocessors (AERs). 510(k) clearance pending. − Defined prototype development strategy and allocation plan, incorporating regression testing to demonstrate production equivalency during development stage.− Managed and maintained detailed project schedule across all functional deliverables.− Led technical and cross-functional design reviews, including project-specific Design for Manufacturability/Assembly and Design for Service initiatives.− Oversaw industrial design efforts with contracted 3rd party firm.− Interfaced directly with Regulatory, Reliability, Marketing, Service, Sourcing and Scientific department leads.− Led support for design transfer activities to non-U.S. manufacturing site.− Performed ongoing product cost analyses and managed project budgets.− Created and maintained Design History Files (DHF), including comprehensive risk management/analysis to drive decision-making.− Helped define alternative design and testing requirements for international product variant for CE marking and conformance to ISO 15883 (specific to washer-disinfectors).• Led multiple technology transfer projects, partnering with domestic and international companies. Projects ranged from transfer of Design History Files (DHF) for an electronic infrared scanner for biological indicators to conversion of a platform washer/disinfector design to customized product specifications.
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  • Steris Corporation
    Director, Systems Engineering, R&D Engineering, Healthcare, Disinfection Systems
    Steris Corporation 2011 - 2013
    Mentor, Oh, Us
    • Responsible for designing and verifying functional improvements to company's flagship liquid chemical high level disinfection global product line, focusing on UV light applications, chemical delivery system, check valve reliability and bacterial retentive filtration; submitted and approved two special 510(k) submissions. − Successfully facilitated Engineering in FDA audit of product line post-launch.• Conducted technology scouting and financial analyses for strengthening business practices and driving sustainable growth (e.g., water disinfection technologies, passive RFID sensing).
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  • Steris Corporation
    Director, Portfolio Development & Strategic Marketing, Pharmaceutical & Research Business
    Steris Corporation 2005 - 2010
    Mentor, Oh, Us
    • Coordinated all portfolio planning and assessment for $200MM global business unit across multiple R&D sites; Oversaw 7x increase in new product revenues over 5 years, representing 13% of total BU revenues in fiscal 2008 (~20% excluding service revenues).− Introduced formal portfolio management review for BU, including concepts of product roadmapping and pipeline planning.− Developed quantitative value creation tools and metrics to identify and prioritize investment opportunities/risks and direct resource allocation to drive short- and long-term growth.• Led voice-of-the-customer process/product discovery project within Laboratory Animal Research segment to improve market share by translating customer requirements to commercial solutions; Defined multiple conceptual designs for prototyping.• Established profitability dashboards for engineered products to help identify commercial/factory variances to plan for customer orders; BU realized 20% GM$ and 8-point GM% improvement over planned performance during fiscal 2008; Defined platform capital offerings to optimize margins.• Influential in re-establishing ‘quote-to-install’ customer fulfillment business processes to improve customer satisfaction and net promoter score.
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  • Steris Corporation
    Senior Program Manager
    Steris Corporation 2003 - 2005
    Mentor, Oh, Us
    • Served as liaison to R&D; Worked directly with product managers and cross-functional product development teams to drive new product introductions across capital/consumable portfolio.• Oversaw annual R&D operating budget for business unit for NPD and sustaining product support activities.• Actively participated in corporate Lean Product Development Steering Committee, which defined internal NPD stage-gate processes and gate review deliverables.
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  • Steris Corporation
    Private Health Care Industry Consultant
    Steris Corporation 2001 - 2003
    Mentor, Oh, Us
    • Submitted and secured FDA 510(k) market clearance for medical device start-up. (Class II endoscopic electrocautery snare/retrievers for gastrointestinal applications)
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  • Biomec, Inc.
    Sales/ Marketing Intern
    Biomec, Inc. Jun 2002 - Nov 2002
    • Customized web-based customer relationship management (CRM) software program and developed project tracking database.• Created technical sales productivity kit for new surgical assist device, including sales strategies and competitive product analysis.
  • Bard Interventional Products
    Director Of Product Development, Senior Project Engineer
    Bard Interventional Products 1996 - 2000
    • Responsible for new product introductions to expand existing line of diagnostic and therapeutic flexible endoscopic accessories and percutaneous devices, specializing in pulmonary instruments; Maintained new product portfolio; Oversaw clinical evaluations.• Authored firm’s first comprehensive product development procedure and design control guidelines; Established and maintained ISO 9001, EN 46001 certification and FDA compliance, working directly with agency auditors. • Identified, evaluated and negotiated joint ventures with both domestic and international medical device manufacturers to capitalize on niche market strengths and to support strategic goals.• Supervised production planning, purchasing and manufacturing during production line transition to offshore manufacturing; Responsible for ramping up product inventory levels during transition.
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  • Tri-Delta Industries
    Senior Manufacturing Engineer
    Tri-Delta Industries 1994 - 1996
    • Supervised team of four manufacturing engineers in start-up of new $15MM Electronics Division.• Responsible for planning layout and workflow of new factory dedicated to printed circuit board assembly, including firm’s first surface mount technology work cell and no-clean solder flux process.
  • Lincoln Electric
    Manufacturing Engineer
    Lincoln Electric 1989 - 1994
    Cleveland, Oh, Us
    • Defined and implemented assembly procedures for new electronic power module incorporating surface mount PCB designs; Realized first-year cost reduction of over $400,000 and 10% reduction in field failures.
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  • Case Western Reserve University
    Electronics Packaging Project Engineer
    Case Western Reserve University 1981 - 1986
    Cleveland, Oh, Us
    • Collaborated with cross-functional team of engineers and clinicians in developing a totally implantable programmable closed-loop control shunt system for monitoring and regulating intracranial pressure; Focus on incorporating state-of-the-art pacemaker packaging techniques.
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Tom Spear Skills

Medical Devices Cross Functional Team Leadership R&d Product Launch Fda Iso 13485 Product Development Design Control Validation Six Sigma Continuous Improvement Manufacturing U.s. Food And Drug Administration

Tom Spear Education Details

  • Weatherhead School Of Management At Case Western Reserve University
    Weatherhead School Of Management At Case Western Reserve University
    Biomedical Engineering
  • Case Western Reserve University
    Case Western Reserve University
    Materials Science And Engineering
  • Case Western Reserve University
    Case Western Reserve University
    Biomedical/Medical Engineering

Frequently Asked Questions about Tom Spear

What is Tom Spear's role at the current company?

Tom Spear's current role is Senior Engineering Project Manager, R&D Engineering, Healthcare, Disinfection Systems.

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What schools did Tom Spear attend?

Tom Spear attended Weatherhead School Of Management At Case Western Reserve University, Case Western Reserve University, Case Western Reserve University.

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Tom Spear has interest in Landscaping, Woodworking, Golf, Sports In General.

What skills is Tom Spear known for?

Tom Spear has skills like Medical Devices, Cross Functional Team Leadership, R&d, Product Launch, Fda, Iso 13485, Product Development, Design Control, Validation, Six Sigma, Continuous Improvement, Manufacturing.

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