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.

 

1 +
Years Software Development
1
SaaS Products
1 +
Employees
1 +
Contractors
1
Patents

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.