R&D Engineering Manager

R D Engineering Manager Dyme Medical Marlborough, MA Job Details Full-time $150,000 - $170,000 a year 11 hours ago Benefits Paid training Stock options Relocation assistance Health insurance Dental insurance 401(k) Paid time off On-the-job training Flexible schedule Qualifications Developing medical devices FDA submissions Managing medical device teams Communication with suppliers Teamwork New product introduction engineering projects Project engineering Quality management standards in production Management Accreditation standards (regulatory compliance area) Requirements design Electrical engineering Collaboration with product development teams Bachelor's degree in engineering Managing engineering teams Bachelor's degree Quality risk management Requirements analysis Medical device design Requirements management Leading team collaboration initiatives Collaboration with manufacturing teams Design controls Biomedical regulatory compliance Regulatory submissions Quality systems Test validation method Research & development Mechanical product validation projects Mechanical knowledge Full Job Description 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:

Bachelor's (Preferred)

Experience:

Medical Device:

10 years (Preferred)

Work Location:

In person