The product development lead role requires both technical project leadership and broad knowledge of strategy of product development and regulatory requirements. Along with driving our design and development processes, I instill innovation and design principles for primarily medical wearable or connected health projects. Our portfolio includes both internal platform products and external client bespoke projects. These projects are confidential unless publicly shared in press, are primarily involve contract design and manufacture of medical devices and/or medical mobile apps for the US and EU market. My specific contributions include designing workshops, crafting device development strategies, leading design work and creating design specifications. I connect with key stakeholders to conduct brainstorming sessions, short cycle development projects, and design sprints as catered to the project and client needs. In my initial role of human factors engineering lead, my responsibility included creating the usability research plan, moderation, and reporting formative and summative usability studies for medical devices seeking eventual FDA approval.
Notable projects: Wearable CGM: https://www.molex.com/en-us/about/case-studies/glucomodicum Home Healthcare Cancer Screening Diagnostic kit: https://www.molex.com/en-us/about/case-studies/exact-sciences Electromechanical Autoinjector licensed platform product: https://www.phillipsmedisize.com/news/phillips-medisize-unveils-aria-smart-autoinjector-platform-to-drive-innovation-and-sustainability-in-digital-drug-delivery/
Phillips-Medisize, a Molex Company, Hudson, WI 05/2022 - Present | Product Development Lead
Define product features and development strategy for device or combination drug delivery development and the activities within client company and vendors
Accelerate development through design sprints, brainstorm workshops, and leveraging agile development tools • Create project schedules for workstreams and manage budget
Lead project team to complete project deliverables, meeting quality, time, and budget
Manage subcontractor or vendor services for seamless execution
Contribute to quoting or statement-of-work efforts
Perform competitive benchmarking or teardown analyses
Communicate technical and program risks, manage monthly financial reports
05/2018 - 05/2022 | Human Factors & Systems Engineer
Author design documentation and product requirements
Plan, execute/moderate formative and summative usability studies for various medical devices for clients
US and International Markets
Propose UX design features for connected health solutions for clients
Incorporate wearable design principles into new product design
Curate collaborations with clients and research vendors to fulfill usability research goals
Lead product usability evaluations, prototyping, and user research
Maintain familiarity with current and new medical device standards and guidances: ANSI/AAMI HE75, IEC 62366, IEC 60601, EU General Data Protection Regulation (GDPR), EphMRA Code of Conduct
CITI training certification
Social/Behavioral or Humanist Research Investigators and Key Personnel Basic (expires: Jan 2022)
Physical Science Responsible Conduct of Research Basic (no expiration)
Note: Human Factors is a disciple of engineering, design and psychology that seeks to understand our limitations and create respectful and assisting devices, processes or technologies. The aim is not to build a complicated, unusable or frustrating product that doesn't suit our need. It respects diverse perspectives and multiple "right" answers while intuitively guiding users to perform the task at hand in the simplest and hassle-free way possible, so that it is almost invisible in operation.