San Francisco Bay Area
I bring 15 years of experience leading the development of complex hardware and software systems—from concept to launch. I navigate ambiguity comfortably, foster a trusting team environment, and focus on delivering high-impact products. I’ve led multiple product launches, managing roadmaps, feature priorities, and go-to-market strategies. My early work on complex medical systems sharpened my ability to break down technical challenges using first principles. I thrive at the intersection of engineering, business, and user success—where hard problems live and real value is created.
From concept to commercialization: Lead development of novel, minimally invasive surgical devices in the field of cardiology. • Perform in-depth market research and create service proposals • Lead contact with the client • Design and build prototypes to assess catheter performance during pre-clinical trials. • Organize pre-clinical studies and create protocol • Plan, organize and manage the resources in order to meet the development milestones • Research and analyse optimal outsourcing options for client • Transfer production processes to contract manufacturer • Plan and execute Design Verification • Create DHF to support CE and FDA submission • Increase team productivity by implementing Agile Project Management practices in the company.
Lead Engineer during the development and successful CE marking of the Needle Injection Catheter (Class III medical device) • Modify and complete development of tri-needle catheter used for stem cell injection in the myocardium • Build early prototypes to evaluate flexibility and deployment of needles during pre-clinical studies • Assist physicians during pre-clinical studies • Lead all aspect of device development and manufacturing. • Transfer processes to serial production. • Custodian of the DHF and support during successful CE submission • Manage a team (Process Engineer, QA Engineer, R&D operator, Production operators) in Munich, Germany for one year. Support Engineering in the development of a transceptal puncture device • Develop heat forming method and production process for PEEK plastics • Participate in pre-clinical studies
Executed and coordinated the technology transfer of a PMMA curing and monitoring vertebroplasty device between the company and university researchers. Designed components, performed design verification and validation. 510k certification obtained. • Performed verification tests and technical support during validation studies (cadaveric) • Drafted and edited sections of the DHF: Product requirements, system specifications, risk management files, protocols and technical reports • Contributed to the development of quality assurance system ISO 13485 in drafting and editing various procedures regarding product development, validation plans and procedures for manufacturing • Obtained certification of the safety of medical electrical systems with CSA in accordance with IEC 60601-1 & -2 • Participated in the certification of the system with various national and international regulatory agencies (Health Canada, FDA, CE)