Summary

Overview

Work History

Education

Skills

Timeline

David Norton

Red Lodge,MT

Summary

Dynamic and results-driven Biomedical Engineer and Program Manager with over ten years of experience in program and project management. Proven expertise in organizational planning, collaboration, and strategic execution, consistently delivering high-quality outcomes in complex environments. Committed to leveraging technical knowledge and leadership skills to enhance project efficiency and drive innovation within a forward-thinking organization. Eager to contribute to long-term or contract opportunities focused on overseeing and optimizing company initiatives.

Overview

years of professional experience

Work History

Risk Management Quality Engineer

RQM+

07.2022 - 01.2025

Performed post market event-based patient safety risk assessments for a major respiratory therapy company.
Risk Management File remediation to the current ISO 14971 standard
Design History File (DHF) remediation to address US FDA and EC nonconformities.

Scheme Manager / Technical Specialist

BSI Group

01.2020 - 05.2021

Managed a portfolio of 27 clients who produce Active Implantable Medical Devices (AIMD) and CE marking clients of the European Notified Body.
Conducted reviews and made recommendations for MDD Renewals and MDR Applications. Performed client Change Notification reviews and approvals, Technical File Assessments in support of EC certification.

Principal Program Management

Phillips-Medisize

05.2018 - 10.2019

Managed medical device development projects in the contract design and manufacturing environment. I managed the control and deployment of 30+ full time equivalent resources and the overall program schedule.
Products included combination diabetes drug delivery devices which integrated thermoplastic and liquid silicone molded components along with active electronic and software components.

Sr. Manager in Program Management

Abbott Inc.

01.2014 - 05.2018

As the team leader for multiple cross functional core teams, I spearheaded large medical device development projects from conception to final release.
Created and managed all aspects of project plans, resource management, milestones, schedules and budgets.
Tracked and managed project performance and risks for the development team and upper management.
Identified and investigated emerging new product opportunities.

Principal Engineer

St. Jude Medical

07.1998 - 01.2014

Medical Device Development and Project Management - Managed many hardware and software projects from product concept to product release. Projects included development of electrophysiology (EP) recording systems, cardiac stimulators and defibrillators, diagnostic ultrasound, patient cabling and an ultra-high definition video display integration system.
Systems Engineering, Component and Software Design – Developed system level requirements, test protocols and test methods. Conducted printed circuit board design and layout, connector and cabling design, mechanical enclosure design. Defined user interface requirements and developed features for the integrated EP Recording and 3D cardiac mapping System.
Manufacturing Engineering and Support – Developed all design transfer documentation including specifications, drawings, work instructions, manuals, quality documentation and risk management documentation (pFMEA). Supported manufacturing and service groups.
Quality Systems and Verification Testing – Managed the return material investigations department. Conducted internal standards compliance testing and managed external product standards testing for system electromagnetic compatibility and patient safety. Managed Technical Support Services for product support, product maintenance, post market surveillance and field support documentation. Conducted complaint investigations.