Requested by senior management to move to California and resolve issues with inability of R&D team to deliver new products. Hired, trained, and guided a group of 6 program managers. Functional management responsibility for 75 engineers.
• Steered team of program managers in successful execution of product development and launch of multiple electromechanical software - controlled drug delivery systems (Plum Pumps, Gemstar, and PCA3) and critical care products (Q2+).
• Facilitated senior-level, cross-functional monthly project meeting, obtaining timely help for critical projects.
• Ensured facility was consistently in compliance by being R&D representative on internal audit committee.

VP Operations (Minute Molecular Diagnostics) August 2020-April 2023Established contract manufacturing relationships, led the RFP (request for proposal) and contract process.
• Multiple vendors needed to be identified and became approved suppliers.
• Completed design transfer and initiated cGMP commercial production.
• Clinical trials required with the diagnostic system prior to FDA submission, the system obtained Emergency Use Authorization.
• Established the quality system strategy and helped author the procedures for this company and it had an external audit with no observations.
• Provided program management to the contract engineering company to ensure they worked within the FDA QSR (quality system regulations) guidelines and the company’s quality management system.

Consultant to BioIntelliSense Inc. (September 2021-July 2022)
Established a PMO (program management office), revised product development processes, developed business processes, and training program to help the company implement the PMO.
• Working with the COO we implemented a product portfolio and a senior management process to review the portfolio monthly.
• The company developed and sold a wearable medical device that communicates with a cloud.
• A significant change management initiative from the CEO and down was required to implement the portfolio and the PMO.

Consultant to Prenosis (September 2021- August 2023)
Provided program management, human factors, cybersecurity, quality, and regulatory guidance for a SaMD (software as a medical device).
• The AI/ML (artificial intelligence/machine learning) medical device was recently submitted for FDA approval.

Senior Program Manager (Abbott Laboratories) April 2021-September 2021
Led a cross functional team developing the quality system documentation and the verification and validation testing required for a 510K submission for an automated diagnostic system.
• Abbott recently acquired a German company that developed and manufactured this system.
• A major focus was on software to control a very complex system and the software to interface with the electronic health record system.

Program Manager (Walgreen Company) June 2020 – August 2020
Develop a business process plan for implementing a new business within a current Walgreens store.

Senior Program Manager (Pfizer Inc.) June 2018 – January 2020
Led 8 combination project cross functional teams. Facilitated a weekly portfolio cross functional leadership meeting. These products are either aseptic sterilized or with terminal sterilization.
• One team was a remediation for an entire product line.
• Convinced senior management to invest $1M in a novel R&D pilot manufacturing line after an extensive due diligence working with a manufacturing teammate.
• Projects ranged from early feasibility, plan clinical trial, to preparing documentation for regulatory filings.
• Participated in a 3- person team pursuing a novel drug container system.

Mentor.