Experience

Prodct

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Partner

  • Aug 2021 - Present

  Prodct is a boutique advisory firm founded specifically to support emerging entrepreneurs and early-stage biotech, medical device, diagnostic, and therapeutic companies. Prodct advisors provide coaching, mentoring, and support for new executives and leaders, especially those unfamiliar with product development and commercialization in highly regulated medical environments.Prodct creates bespoke development, quality, and manufacturing strategies aligned with 21 CFR part 820, 21 CFR part 11, ISO 13485:2016 and ISO 14971:2019. We underwrite our advice with execution support, including resource augmentation when necessary.My North Star always points us back to Risk Management. When I collaborate with teams to establish ISO 14971:2019 compliant Risk Management Files (RMF), we implement a set of tools to capture the unique collection of risks for each product. I coach firms in risk-based thinking, and in integrating risk reduction methodologies strategically throughout the product development cycle. We start the RMF early, iterate often, and place it in the center of our thinking as we prioritize safety and efficacy of our patients. Show less

• Advisor

  • Oct 2020 - Aug 2021



myBiometry

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director Of Quality

  • Apr 2021 - Present

  myBiometry is focused on one of the biggest healthcare problems in the world, asthma. Our mission is to help asthma patients prevent symptoms and attacks. Our solution combines digital health, patented sensor and device technology, machine learning, and clinical oversight to turn biomarker data into actionable insights. myBiometry is focused on one of the biggest healthcare problems in the world, asthma. Our mission is to help asthma patients prevent symptoms and attacks. Our solution combines digital health, patented sensor and device technology, machine learning, and clinical oversight to turn biomarker data into actionable insights.



Kasota Engineering LLC

• United States
• Medical Device

• Founder

  • Nov 2016 - Present

  I help startups and small firms navigate concept-to-launch Product Development and Quality. I create customized, ISO 13485:2016 and 21 CFR Part 820 compliant Quality Management Systems (QMS), remediate QMS-based regulatory notices, and author Design History Files (DHF) and ISO 14971:2019 compliant Risk Management Files (RMF). I often bridge the gap between engineering teams and executive management, helping to translate and communicate requirements to stakeholders. My coaching highlights risk-focused decision making and process implementation wherever possible. Show less



Sonablate Corp (SonaCare Medical)

• Product Development Engineer

  • Dec 2012 - Mar 2017

  I led the design & development of three single-use kits for therapeutic ultrasound systems from concept origination through product verification, validation, creation of quality procedures, launch, and initial commercial use in the US. I managed multiple major, cross-functional projects requiring 10,000 hours each and a team of 12, including marketing, sales, engineering, quality, manufacturing, and supply chain. I also enjoyed coaching multiple young engineers new to medical devices. Through owning the risk management files compliant with ISO 14971, I kept user/patient safety at the forefront and instilled a patient-centric culture in my team. Show less



Hologic, Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Sustaining Engineer

  • Aug 2011 - Dec 2012

  I led design and product quality for biopsy device ($50 MM annual revenue), including evaluating complaints, all project documentation, redesigning for DFM/cost reduction ($75k annual savings) & product transfer to Costa Rica. I provided technical support to regional sales specialists, clinical education specialists, and manufacturing. Working with the world-class team at Hologic, I learned what it looks like to keep a patient-centric focus throughout development and manufacturing-- and to keep my eyes on Risk Management as a guide in design, process development, and customer feedback. Show less



GE Aviation

• United States
• Aviation and Aerospace Component Manufacturing
• 700 & Above Employee

• GE Aircraft Engines Design Engineer

  • Jul 2009 - Aug 2011

  In this role at GE, I analyzed the design, manufacturing, test, and integration required to define and support the development of the oil system for the F136 fighter engine used on the Joint Strike Fighter and coordinated multiple component rig tests at once, managing multiple locations, suppliers, and budgets. This role encouraged me to dive deep in my niche area, which led me to understand my strength of having a system-perspective and holistic view of problems. In this role at GE, I analyzed the design, manufacturing, test, and integration required to define and support the development of the oil system for the F136 fighter engine used on the Joint Strike Fighter and coordinated multiple component rig tests at once, managing multiple locations, suppliers, and budgets. This role encouraged me to dive deep in my niche area, which led me to understand my strength of having a system-perspective and holistic view of problems.



Purdue University

• United States
• Higher Education
• 700 & Above Employee

• Custom Prosthetic Leg Design and Fabrication

  • Aug 2008 - May 2009

  I found my love of medical device development in my last project at Purdue University as a senior, designing, fabricating, fitting, a custom prosthetic leg for a 12-year-old with unusual leg geometry. The project was a simple four-bar linkage that extended his residual limb and allowed him to ride a bike for the first time ever. It was all over for me when he flashed the huge smile pedaling on the bike trainer the first day he put on his new leg. I learned some design skills, used a few machines and tools... but this project pulled my heart into the business of helping people and improving quality of life. It took a few years after graduation to get back to medical devices, but this is where the love affair started and I will be forever grateful to him and to Purdue for teaching me to use my skills for good. Show less

• Resident Assistant

  • Jan 2008 - May 2009

  As a Resident Assistant, I had the opportunity to live alongside and serve the women of Windsor Hall at Purdue University. We studied, formed healthy habits, learned about inclusivity, solved crises, talked about poor choices, celebrated good choices, cried, --but mostly laughed together.