Overview

Jonathan Broadwell is an experienced engineer who has helped bring compliant medical medical products to market. Jonathan’s focus is software development that is compliant with IEC / EN62304, and risk process execution that is compliant with ISO14971.

Experience

Principal Engineer and CEO, Broadwell Consulting Inc (2019-Present):

• Formed in 2019, Broadwell Consulting Inc has provided Jonathan’s services to multiple IVD companies to assist in product development and regulatory compliance, including medical product development, medical project management, software development, and design history file remediation

Director of Engineering, PTS Diagnostics (2014-2019) :

• Supervised and Directed a mixed Engineering Department of 11 people (Direct reports included Firmware, Software, Electrical, Systems, V&V, and Mechanical Engineering positions) with a base salary budget in excess of $1M.

• Oversaw improvements to the CardioChek PA and CardioChek Plus line (the company's two premier products based on optical and electrochemical technology), as well as the launch of 6 separately marketed accessory products, mostly related to wired and wireless connectivity (Bluetooth 2.0, BLE, WiFi, USB).

• Directly represented engineering during FDA and Notified Body (CE Mark) audits. Worked with Head of Quality to resolve observations when found.

• Departmental responsibilities included recruiting and hiring, performance evaluations, project assignment, and reporting to executive team.

• Assisted Global Product Development VP in annual department budget, team effort allocation, and roadmapping process.

• Provided engineering consultation to cross-functional teams evaluating new business and product opportunities

• Supervised implementation and verification of CAPAs related to engineering products and processes

• Visited and interacted with customers and strategic partners when engineering expertise was needed.

• Provided occasional Subject Matter Expertise in Software and Firmware development. Created a new in-source documentation system which auto-generated Requirements, Design, Risk, and traceability items along with a full Software Development plan in order to create a single unified document which was compliant with EN 62304 for 'B' level of concern software.

Senior Technical Specialist, LHP Software (2002-2013):

Project lead and technical consultant on embedded systems projects, typically hard real-time systems written in C code and utilizing real-time executives or RTOS systems. Specialized in system architecture, building and documenting systems which utilized CAN and other communication systems to interface to sensors, brushed and brushless DC (BLDC) motors, battery charging systems, and other equipment. About 50% of projects were focused on automotive systems, primarily engine control ECMs or accessories such as motor drives.

Senior Software Engineer, Logikos (1999-2002)

Worked on embedded firmware teams developing projects for customers in the Diesel Engine, Heavy Duty Construction Equipment, Automotive Entertainment, and Automotive Accessory areas

Computer Lab Assistant, Tri-State University (1996-1999)

Working at Tri-State's computer lab was one of the formative experiences of my career. At Tri-State, many of the non-technical majors had requirements that could be fulfilled by a variety of different electives, one of which was computer science. This had the effect of directing non-technical people into C programming classes. In an era before many people had dial-up access to the internet, people would come down to the computer lab to complete their programming assignments on the Digital Equipment Corporation VAX (similar to a mainframe). As a steward of the many text-only VT-220 terminals that made up the lab, I had the interesting experience of teaching concepts such as pointers, structures, unions, and linked-lists to liberal-arts, education, and other traditionally non-technical majors. It was in this role that I honed my ability to convey technical concepts to people who lacked a strong technical background. I developed a fluency in analogy and metaphor which has helped me in cross-functional relationships throughout my career.