Corporate Officer Quality Manager

Todd Koeppel

****** Highway ** – Sandpoint, ID **864

208-***-**** (home) 818-***-**** (cell)

****.*******@*****.***

SUMMARY OF QUALIFICATIONS

Over twenty years of experience as a quality, project and electrical design engineering and management working with various cross-functional groups in medical and electronics industries to improve performance and reliability and reduce manufacturing costs and continually improve on a wide variety of products and systems.

ENGINEERING & QUALITY MANAGEMENT EXPERIENCE

PERCUSSIONAIRE CORPORATION, SANDPOINT, ID May 2022 – Dec 2022 QUALITY MANAGER (QUALITY SYSTEMS, DEVELOPMENT & MANUFACTURING)

• Quality System Management for all aspects of respiratory therapy device production and development

• Managed Quality Assurance and Quality Control team members

• Maintain Quality Management System compliant to ISO 13485:2016

• Implemented significant revisions to Corrective Actions, First Article Inspection, and Supplier Management processes

• Responsible for setting priorities and delegating tasks to various personnel to ensure product quality and continual improvement and ongoing compliance to QMS requirements ENCODER PRODUCTS COMPANY, SAGLE, ID Oct 2018 – May 2022 QUALITY MANAGER (QUALITY SYSTEMS, DEVELOPMENT & MANUFACTURING)

• Quality System Management for all aspects of rotary shaft encoder production and development.

• Managed Quality Assurance and Quality Control team members

• Management Representative for ISO 9001 audits to maintain compliant Quality Management System

• Corporate Officer delegate on corporate officer team for over 1 year

• Implemented significant revisions to Corrective Actions, First Article Inspection, and Supplier Management processes

• Responsible for setting priorities and delegating tasks to various personnel to ensure continued compliance to QMS requirements

ENVOY MEDICAL CORPORATION, St. Paul, MN Mar 2015 – Oct 2018 QUALITY MANAGER (QUALITY SYSTEMS, DEVELOPMENT & MANUFACTURING)

• Quality System Management for all aspects of Active Implantable Medical Device production, development, and regulatory compliance

• Management Representative for EU Notified Body audits to AIMD & ISO 13485 for the purpose of renewal and maintenance of CE Certification

• Host FDA inspections for compliance to 21 CFR Part 820 PMA implantable medical devices

• Co-managed facility site transfer and obtained regulatory approvals from EU and FDA

• Implemented numerous revisions to entire Quality Management System for ISO and CFR compliance

• Responsible for setting priorities and delegating tasks to various personnel to ensure continued compliance to QMS regulations

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ENVOY MEDICAL CORPORATION, St. Paul, MN June 2014 – Mar 2015 SR. QUALITY ENGINEER (QUALITY SYSTEMS, DEVELOPMENT & MANUFACTURING)

• Rewrote, implemented, and managed an entirely new CAPA system, compliant with 21 CFR Part 820 and ISO 13485

• Revised Risk Management system to align with ISO 14971. Primary focus on FMEA and Hazard Analysis

• Integrated Returns system into complaint system and performed Returned Product analysis

• Led monthly Quality System status report meetings, set metrics and trending thresholds ST. JUDE MEDICAL INC., St. Paul, MN Oct 2007 – June 2014 SR. QUALITY ENGINEER (QUALITY SYSTEMS, DEVELOPMENT & MANUFACTURING)

• Certified ISO 13485 Lead Auditor

• Instituted robust CAPA and NCMR system to improve quality system, and product nonconformance issue tracking

• Compile Risk Management File documentation including FMEA, Hazard Analysis, and Risk Assessment reports

• Complete Master Validation Plans, IQ/OQ/PQ/PPQ, and other various validation projects

• Arranged for agency safety testing to IEC/EN/UL/AAMI 60601-1 and collateral standards resulting in CB Scheme Certification and agency safety marking for Europe, US and Canada.

• Wrote manufacturing safety test specifications and worked with manufacturing to develop test systems to ensure that all product meets or exceeds the minimum requirements for safety MEDTRONIC INC. (PHYSIO-CONTROL), Redmond, WA May 2005 – Oct 2007 SR. PROJECT ENGINEER

• Manage Lifecycle Projects for implementation of design changes to medical devices and systems including planning of document changes, verification, validation, qualification, system impact and process impact.

• Review and approved verification, validation, and qualification plans and protocols.

• Work closely across many disciplines within the company, with suppliers and contract manufacturers, to ensure projects were completed successfully and on time.

• Respond to problems arising from field issues, production yields, supplier changes, and other quality issues. Managed investigations and implemented corrective and preventive actions.

• Propose process changes to streamline change projects for increased speed and efficiency. MEDTRONIC INC. (PHYSIO-CONTROL), Redmond, WA Oct 2001 – May 2005 ELECTRICAL ENGINEER

• Led product evaluation project for cardiac defibrillator during 1st full year in field to quickly determine root cause and prioritize issues based on risk in order to focus engineering efforts.

• Led several formal medical product CAPA investigations to determine root cause of complicated system failures in cardiac defibrillators to implement effective corrective and preventive actions.

• Worked with customers to improve relations and build confidence in company products.

• Worked with an engineering team to develop a new Li+ battery charger and power management circuit.

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ALCATEL INTERNETWORKING, Spokane, WA 2001

CONTINUATION/COMPONENT ENGINEER

• Solved microprocessor-reset issue causing problems on all printed circuit assemblies.

• Researched digital and analog component issues to save company over $100,000/year in procurement and manufacturing.

• Helped design engineers source cutting edge electronic components including gigabit and 10gig Ethernet transceivers, microprocessors, network processors, and switch fabrics. AGILENT TECHNOLOGIES, Liberty Lake, WA 2000 - 2001 MATERIALS ENGINEER

• Helped design engineers source analog electronic components to ensure best possible price and availability for new designs.

• Found and resolved many component procurement issues to avoid future reliability problems.

• Updated design guide for electronic component selection. LEAD-LOK, Sandpoint, ID 1999 - 2000

ENGINEERING CONSULTANT (Evenings On-Call concurrent with Encoder Products Co.)

• Designed electrode packaging machine using PLC, pneumatic valves, position sensors, and stepper motor.

• Solved design flaws to improve performance and product output of electrode machine by over 400%.

ENCODER PRODUCTS CO., Sandpoint, ID 1998 - 2000

APPLICATIONS ENGINEER

• Designed software for test fixture for temperature testing of incoming wire-bonded sensors.

• Redesigned rotary shaft encoder electronics to improve performance, component availability, reduce manufacturing time and effort, and maintain current manufacturing cost.

• Worked with customers to resolve electrical and mechanical interfacing issues with our products in variety of applications.

EDUCATION

B.S., ELECTRICAL/BIOMEDICAL ENGINEERING, COMPUTER SCIENCE MINOR University of Wyoming, Laramie, WY

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