Job Overview We're looking for an experienced engineer to provide system-level technical leadership for the development of a next-generation insulin pump. You'll lead cross-functional product development spanning requirements, architecture, risk management, verification and validation, and design transfer in a regulated medical device environment, and you'll get to see it through to real patients. This is a hands-on senior individual contributor role, not a people-management position. The ideal candidate pairs deep medical device expertise with strong technical judgment, project management, and the drive to own outcomes and push work to closure. Key Responsibilities Serve as the technical lead for cross-functional development of the Dyme Insulin Pump. Provide day-to-day technical leadership across R&D to align priorities, schedule, and execution. Contribute to product requirements, system specifications, architecture inputs, and technical documentation. Drive the technical planning behind key product objectives, including V&V strategy, test planning, and design readiness. Develop project plans, technical schedules, and task priorities to hit development milestones and deliverables. Coordinate technical execution across the engineering team and support activity at external development partners. Contribute directly as a hands-on engineer by owning individual technical tasks and deliverables. Partner with Manufacturing Engineering on design-for-manufacturability and work instructions. Collaborate with Engineering and Quality to maintain design control documentation, including the DHF and DMR. Contribute to risk management activities, including FMEA, hazard analysis, risk assessment, and mitigation planning. Thrive in a startup-style environment that rewards initiative, flexibility, and cross-functional collaboration. Regulatory and Standards Knowledge Working knowledge of, and hands-on experience applying, the regulations and standards most relevant to insulin pump and connected medical device development: FDA Quality System Regulation / QMSR expectations (21 CFR Part 820) and practical application of design controls. FDA development and submission expectations for Class II devices, including experience supporting 510(k) submissions.

ISO 14971

for risk management across design, verification, manufacturing, and post-market. Traceability, verification, validation, and design transfer needed to support DHF and DMR readiness. Required Qualifications Bachelor's degree in Mechanical Engineering or a related engineering discipline; advanced degree preferred. Strong mechanical engineering background, with working knowledge of electrical and software systems in an integrated product. Significant medical device development experience with Class II electromechanical, software-enabled devices. Direct experience supporting products through the 510(k) process. Demonstrated experience leading system-level product development in a regulated environment. Strong grasp of design controls, requirements development, risk management, V&V, and regulated product documentation. Experience working with manufacturing, quality, regulatory, suppliers, contract manufacturers, and external development partners. Strong written and verbal communication, with the ability to influence cross-functional teams and drive technical closure. Creativity, initiative, and strong technical problem-solving; patent or invention history is a plus. Comfort leading through influence, without formal direct reports.

Pay:

$140,000.00 - $160,000.00 per year

Work Location:

In person