Suggestions
David Shanes
Executive Vice President Engineering at TruMed Systems, Inc.
David Shanes is a seasoned professional with extensive experience in the medical device and technology industries. He currently serves as the Vice President of Regulatory Affairs at Fullpower-AI, a position he has held since January 2022.13 In this role, he manages the company's regulatory and compliance efforts, focusing on advancing solutions in the healthcare and medical device spaces.
Prior to his current position, Shanes held several executive roles, including:
-
Executive Vice President of Engineering and Chief Security Officer at TruMed Systems, Inc., where he oversaw all Engineering and maximized engineering and manufacturing performance.24
-
President of Device Design Solutions, a company he founded in November 2017 to help businesses complete their medical device systems on time and within budget.1
-
Vice President of Quality and Regulatory Affairs at Biocare Medical.2
-
Vice President of Research and Development at BioTelemetry, Inc..2
Shanes has a strong educational background, holding a Bachelor of Science in Computer Science from the United States Naval Academy and a Master of Science in Computer Science from San Diego State University.2 He is also a U.S. Navy veteran.1
His areas of expertise include:
- Engineering and R&D leadership
- Manufacturing
- Quality and regulatory affairs
- Medical device development
- Software and hardware systems
- FDA compliance and quality management systems
Shanes is known for his strategic approach to driving small to large global teams and has a track record of success in complex systems integration.1
Highlights
How do YOU like your coffee?
Why is this line so important for me?
- It's collaborative
- It's empathetic
- It's supportive
These are all things that we want, and NEED, at work. It means that someone else is noticing that you are stressed, overworked, feeling anxious, feeling behind, feeling like the bottleneck on the project.
It's what we do to help each other.
In product development, different groups/teams/people can feel overwhelmed at different points throughout the product lifecycle. Everyone is busy (read: stressed, freaked out, overworked, exhausted, etc...) at different times in the project.
- Marketing is late in getting the User/Market requirements documented.
- Project managers are trying to disassemble their project schedules and put them back together to meet committed dates that might just be a little unrealistic (gasp, never).
- Engineers are feeling overwhelmed by having to architect, design, develop, and test the project to meet deadlines. And, nothing ever changes; right? Feature creep anyone?
- Manufacturing is panicking to find suppliers for parts that had last minute spec changes, unknown order volumes, sudden change requests, suppliers that Quality would not approve.
- Verification, validation, usability testing, user acceptance are time crunched because, well the delivery date can't change.
- Regulatory is rushing to put together a regulatory submission for a product with changing document contents and ever changing version numbers.
So... When I am done with my work and handing it to you or waiting for your work so you can hand it to me....
How do YOU like your coffee? Double Gulp size with extra sugar?
Let me get that for you. I am here to help...
#culture #collaboration #empathy #communication #conflict #productdevelopment
