R&D Engineering Manager

About the role

You will lead and mentor a team of engineers in a fast-paced medical device environment, driving the development of minimally invasive surgical stapling solutions. You will own the technical direction and execution of the R&D Handle team, ensuring alignment with company quality and compliance standards. You will translate high-level product requirements into actionable plans while managing priorities, timelines, and cross-functional dependencies. You will serve as a hands-on technical leader, reviewing documentation and acting as the primary escalation point for complex engineering challenges. You will champion continuous improvement across the product lifecycle, from concept development through design transfer and sustaining activities. You will own critical product documentation, including the Design History File, to ensure traceability and regulatory compliance. You will collaborate closely with regulatory, quality, supply chain, and operations to remove roadblocks and drive successful project outcomes.

Key facts

What you'll do

Lead and mentor a team of 3-5 engineers across sustaining and active product development programs for surgical stapling platforms.

Build and develop a high-performing team through performance management, career development, skill-building, recruiting, and onboarding.

Participate in high-level product definition and translate requirements into detailed design and actionable project plans.

Proactively identify resource gaps and project risks, communicating status and escalations to company leadership.

Serve as a technical resource and escalation point, reviewing and approving engineering documentation, change orders, and risk management files.

Own the Design History File (DHF) and all relevant product documentation, ensuring accuracy and compliance during development and design transfer.

Collaborate cross-functionally with Regulatory Affairs, QA, Supply Chain, and Operations to support product initiatives and process improvements.

Drive end-to-end project execution with full ownership of outcomes for complex mechanical and electromechanical projects.

Apply first-principles mechanical engineering fundamentals and proficiency with SolidWorks to develop innovative surgical solutions.

Ensure strict adherence to design controls and quality systems such as ISO 13485 across all phases of development and sustaining.

Leverage experience with electromechanical devices to guide system integration and manufacturability decisions.

Champion a culture of innovation, continuous improvement, and safety within a regulated medical device environment.

Provide leadership in problem-solving, using root cause analysis and critical thinking to resolve complex technical issues.

Support the commercialization of products that improve surgical outcomes and advance minimally invasive procedures in a growing market.

Requirements

Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related field.

7+ years of product development experience in a medical device or regulated environment.

2+ years of experience leading development teams through complex technical projects from concept to production.

Must have led end-to-end project execution with full ownership of outcomes and accountability for delivery.

Demonstrated ability to bring a product from initial concept development through transfer to production and commercialization.

Strong leadership skills with the ability to energize, empower, and unite a team in pursuit of shared goals and high standards.

Excellent time management skills with a proven ability to meet demanding deadlines while managing multiple priorities.

Ability to delegate and prioritize tasks effectively in a fast-paced, dynamic engineering environment.

Excellent organizational skills and meticulous attention to detail in documentation and design processes.

Strong problem-solving skills, including root cause analysis, critical thinking, and data-driven decision-making.

Proficiency with SolidWorks and parametric 3D modeling tools for mechanical design and validation.

Strong understanding of design controls, quality systems, and regulatory requirements such as ISO 13485 across all development phases.

Experience with electromechanical assemblies, actuation mechanisms, and device integration is highly valued.

Nice to have

Experience in a surgical stapler or other surgical device platform.

Familiarity with smart manufacturing processes and digital tools in a medical device setting.

Practical notes

This is an onsite position based in Bedford, Massachusetts, near Boston.

The role involves full-time hours during standard business operating days.

Candidates must be eligible to work in the United States without sponsorship for this position.