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

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Preferred)

Experience:

• Engineering: 5 years (Required)

Work Location: In person