Regulated Software and Medical Device Expert
20+ years experience in cradle-to-grave regulated product management including business analysis, feature innovation, software engineering, systems architecture, design assurance, quality systems, product marketing, launch management, FDA submissions, and more.
My customers, competition, and market aren’t waiting for answers.
Everyone prefers working with an experienced software expert.
Vision
Defining the company vision and strategy.
8+ years working with cross-functional teams to understand the company goals, defining a strategic plan, and executing on the company vision with measurable success.
Roadmap
Boosting team confidence with a strong engineering roadmap.
15+ years as a software product manager bringing new ideas into the product pipeline and using my technical experience to plan out a realistic product roadmap.
Scaling
Scaling, building, and mentoring teams for growth.
In-depth experience structuring the organization for exponential growth and using my leadership to build strong, self-sufficient and independent team(s).
FDA
Preparing submission packages with strong and effective copywriting.
Successfully completed 6 FDA 510(k) submissions with good submission copywriting and delivering a complete package.
Procedures
A quality system isn’t just good practice, it is necessary.
With my engineering experience, I can standardize current processes or create new procedures that “makes sense” to an engineering team.
Budgeting
Understanding the P&L to make the best financial decisions.
As a general manager, I have extensive experiencing managing and overseeing budgets. I help create a top-down and bottom-up budget for the business.
Innovative Thinking
Using systematic and proven methodologies to innovate.
I have been preaching the systematic innovative thinking mindset for over 10+ years. You don’t have to be a genius to discover new opportunities.
Problem Solving
Use foresight to avoid problems before they emerge and creativity to resolve them.
Whether it is a business problem or technical engineering problem, I am the go-to person to find solutions.
Project Recovery
Saving struggling projects and stopping the bleeding.
I have a 100% project recovery rate. My engineering background lets me take a “hands-on” approach to identifying the root cause for project performance.