Derek Hillstrom Email & Phone Number

Belmont, California, United States

San Francisco, California, US

-Responsible for product development, engineering, and operations for a Class II bone vibration technology for prevention and delay of osteoporosis-Lead development activities, including management of engineers, consultants, and assemblers, of the next-gen product for commercial launch-Provided technical and clinical data analysis for FDA de Novo.

Providing product development and manufacturing knowledge on a variety of projects:- Temperature control hardware- Women's health products- Government funding applications- Productivity Apps

• Responsible for development of all next-generation wireless devices using NFMI technology to transfer audio and data from inside the body.
• Responsible for manufacturing the NFMI communication devices using bone conduction through the teeth.
• Manage the engineering team, including electrical, mechanical, and software engineers, plus the materials manager, QA tech, and dental technician.
• Lead product development process for next-gen product releases using agile methodologies.
• Ran budget scenarios, product development roadmap, COGs projections, build and delivery forecasts, and inventory valuations.
• Developed business roadmaps, forecast assumptions, and product release roadmap for due diligence efforts.

• Manage the operations team, including materials manager, QA tech, dental technician, and manufacturing engineer.
• Transferred production to contract manufacturer for turn-key builds.
• Developed test systems for component testing at contract manufacturer.
• Ran budget scenarios, COGs projections, build and delivery forecasts, and inventory valuations.
• Created simple MRP system to quickly manage inventory and purchasing.
• Developed and released SOPs for Document Control, Purchasing, Equipment Control, and Product Development.

Redwood City, California, US

• Responsible for manufacturing a Class II muscle stimulator for chronic care patients.
• Managed the operations and development teams, including 2 development engineers, 2 technical operators, and 1 manufacturing tech.
• Development of a next generation muscle stimulation controller with improved ID, output power and efficiency.
• Researched the improvement in muscle stimulation when using cold to change the electrical conduction pathways.
• Improved COGS 50% by using a flexible thin FR4 to replace the flex circuit.
• Analyze inventory levels based on sales forecast and current throughput/yield and communicate build schedule to the operations team.

• Responsible for day-to-day operations manufacturing a Class III active implantable medical device (neurostimulator for severe headaches), the associated handheld remote controller, and surgical tools.
• Manage the operations team, including materials manager, 6 technical operators, 2 manufacturing engineers, and shipping clerk.
• Project Lead for the active placebo stimulator used in the US IDE clinical trial.
• Researched the stimulation parameters for the active placebo stimulator, conducted the human use safety study, documented the user needs and product requirements, managed V&V activities and design transfer to.
• Completed projects to transition handheld remote controller to RoHS compliance and to update labeling for commercial launch of the Pulsante microstimulator.
• Analyze inventory levels based on sales forecast and current throughput/yield and communicate build schedule to the operations team.

St. Paul, Minnesota, US

• Project Lead for development of a next-generation RF catheter generator.
• Project team consisted of 5 engineers and multiple consultants.
• Documented product requirements (hardware and software) working with regulatory, marketing, and clinical.
• Managed hardware and software design from concept through validation.
• Integrated hardware and software for feasibility and validation phases.
• Responsible for documentation of validation testing for FDA compliance.ACS Program Manager, R&D

Bs, Aerospace, Aeronautical And Astronautical Engineering

Certificate, Management