Tom Spear Email & Phone Number

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.

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).

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.

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.

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)

• 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.

• 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.

• 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.

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.

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.

Master Of Business Administration (Mba), Materials Science And Engineering, Biomedical Engineering

Master Of Science (Ms), Materials Science And Engineering

Bachelor Of Science (Bs), Biomedical/Medical Engineering