Job Overview
We are seeking an experienced R&D Manager to provide system-level technical leadership for the development of a next-generation Insulin Pump. This individual will lead cross-functional product development activities spanning requirements, architecture, risk management, verification and validation, and design transfer in a regulated medical device environment.
This is a hands-on senior individual contributor role, not a formal people-management position. The ideal candidate combines deep medical device expertise with strong technical judgment, project management, execution skills, and technical leadership.
Key Responsibilities
· Serve as the technical lead for the cross-functional development of the Dyme Insulin Pump.
· Provide day-to-day technical leadership across R&D activities to align priorities, schedule, and execution activities.
· Participate in development of product requirements, system specifications, architecture inputs, and technical documentation.
· Drive technical planning needed to achieve key product objectives, including verification and validation strategy, test planning, and design readiness.
· Develop project plans, technical schedules, and task priorities in support of development milestones and deliverables.
· Coordinate technical execution of engineering team and support activity at external development partners.
· Contribute directly as a hands-on engineer by completing individual technical tasks and deliverables.
· Partner with Manufacturing Engineering to support design-for-manufacturability goals and development of work instructions.
· Collaborate with Engineering and Quality to maintain design control documentation, including the Design History File (DHF) and Device Master Record (DMR).
· Contribute to product risk management activities, including FMEA, hazard analysis, risk assessment, and mitigation planning.
· Work effectively in a startup-style environment that requires initiative, flexibility, and strong cross-functional collaboration.
Regulatory and Standards Knowledge
The ideal candidate should have working knowledge of, and experience applying, the regulations and standards most relevant to insulin pump and connected medical device development, including:
· FDA Quality System Regulation / Quality Management System Regulation expectations (21 CFR Part 820) and practical application of design controls in a regulated development environment.
· FDA development and submission expectations applicable to Class II medical devices, including experience supporting 510(k) submissions.
· ISO 14971 for medical device risk management across design, verification, manufacturing, and post-market considerations.
· Traceability, verification, validation, and design transfer expectations required 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 environment.
· Significant experience in medical device development, involving 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 understanding of design controls, requirements development, risk management, verification and validation, and regulated product documentation.
· Experience collaborating with manufacturing, quality, regulatory, suppliers, contract manufacturers, and external development partners.
· Strong written and verbal communication skills, with the ability to influence cross-functional teams and drive technical closure.
· Demonstrated creativity, innovation, and technical problem-solving; patent or invention history is a plus.
· Comfort leading through influence without formal direct-report management.
Pay: $150,000.00 - $170,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- On-the-job training
- Paid time off
- Relocation assistance
- Stock options
Education:
Experience:
- Medical Device: 10 years (Preferred)
Work Location: In person
