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David Shanes
Executive Vice President Engineering at TruMed Systems, Inc.
David Shanes is a seasoned professional in the fields of engineering, research & development, manufacturing, and quality & regulatory leadership, with a background as a Navy veteran.
He is a champion of technology, engineering innovation, quality, and compliance. David has held progressive leadership roles at the VP level and above, driving strategic initiatives within small to large global teams and demonstrating a consistent track record of success.
His expertise spans systems, software, hardware, and biomedical engineering, specializing in product/project management and manufacturing leadership. With a strong focus on systems integration, he excels in software and hardware definition, design, implementation, and support across various system and wireless architectures.
As a quality and regulatory leader and executive, David excels in designing, implementing, and overseeing Quality Management Systems and compliance programs to ensure top-notch standards are met and maintained.
David Shanes possesses core competencies that include strong integrity, ownership & accountability, strategic vision, product development, manufacturing proficiency, exceptional communication & interpersonal skills, and adeptness in relationship/culture building. He is skilled in global team building, mentoring, risk/change management, budgeting, and selecting the right tools and processes for optimal outcomes. Additionally, David has vast experience in system/software design and development, global vendor selection & management, FDA regulations, and compliance standards such as QSR, GMP, ISO 62304, 14971, 13485, 62366, 60601, and MDSAP.
David's educational background includes 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.
His professional experience includes serving as the Executive Vice President of Engineering at TruMed Systems, Inc., and formerly as the President of Device Design Solutions.
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
