Ray Still, P.E. Email & Phone Number

Mentor, Ohio, United States

• Experienced in analysis and representation for the voice of the customer.• Drives business critical projects from concept development to post market release analysis.• Guides the build vs. buy decision by providing timely research and recommendations through a an understanding of current and future state of available technology and forecast budgets. • Serves as Medical Device Single Audit Program (MDSAP) audit representative group.• Assist in the strategic oversight and operational management of our partner vendors including vetting, contract negotiations, escalation and termination of vendor services.• Advises and assign tasks to engineers regarding best practices, internal/external standards, and resources required to move their projects forward.• Travels both domestic and international to support new product development and supplier relations.-Patents at STERIS Inc.

Mentor, Ohio, United States

• NAMSA certified Bio-compatibility Specialist.• Business group Hazardous Communication (HAZCOM) owner for new materials that may be used for R&D, new products or new manufacturing processes.• Lead for medical device sterilization that may include EO, Pre-Vac Steam, Bio-burden, Fractional Studies with focus on TIR 28(2016) compliance.• Manages capital tooling and equipment purchases with vendors.• Recommends and justifies the purchase of new technology for the business group to leadership.• Study director for beta testing and user acceptance testing, if applicable – pilot programs, to measure the effectiveness of the products and value propositions.

Mentor, Ohio

• Lead new documentation requirements to support 510(k) submissions which improved FDA 510(k) first review clearance rate(s).• Work with physicians to establish customer needs and translates the needs into product requirements.• Evaluates and applies design tradeoffs and constraints for design optimization within a project.• Established product development process chart to show visually what occurs in a project. (Stage Gate with dashboards)-Patents at US Endoscopy

Middleburg Heights, Ohio

• Project lead in charge of managing plant project activities, new product design, process improvements, resource estimating, technical presentations, design reviews, project updates, protocol writing, medical product line extensions, and new product commercialization through 510(k) submission.• Managed offsite (Out of State) medical device projects.• Trained Green Belt (Operational Excellence Group). Managed plant Lean Six-Sigma events.

Cleveland,Ohio

New Product Design and Development Engineer (2002 – 2005) Manufacturing and Industrial Engineering Project Manager (1999-2002)• Designed/Developed new consumer products with use of an ideation team and client inputs.• Designed/Developed Automation equipment from small work cells to large machinery.• Technical Manual writer.• R&D for High-temperature, non-catalytic, infrared heater to serve thermoforming industry• Managed and coordinated recruitment of Co-oP’s-Patents at Ranpak and Kirby.

Cleveland, Ohio, United States

Machinist: CNC (3-Axis), EDM (Sinker/Wire), Welder (Mig/Tig) and Laser (Yag)Assembly line worker/ Assembly line technician/ Production SupervisorDevelopment R&D models for engineering(Cardboard, Renshape, SLA)

Identify, analyze and provide solutions for quality related problems and opportunities. (SPC) Data entry, creating, filing, organizing and communicating documents as required. Conducts/Facilitates problem solving. Initiate actions to prevent the occurrence of any non-conformities relating to product, processes and quality system. Interface with plant, engineering, customer, supplier, personnel to enhance introduction of new parts into production. Driving continual improvement in the supply base through successful execution of Quality tools. Working with Manufacturing Engineering and Production Operations in the development of Process FMEAs, Process Control Plans, Measurement System Analyses, and Process Capability Methods & Requirements.HIGHLIGHTS>Responsible for 747 landing gear SPC>Part Manufacturing Supervisor>Manufacturing, Tool and Quality Control Assistant