Mechanical Engineer

About the role

This position centers on end-to-end ownership of surgical stapling hardware development within our Bedford, Massachusetts team. You will guide concepts from initial intake through detailed design, validation, and transfer to production. The role supports three core mechanical groups: reload mechanisms, manual handles, and power handle systems. Your work will directly influence devices used in minimally invasive procedures across a growing market. The position is hands-on and requires engagement with complex mechanical and mechatronic systems. Team members have the opportunity to impact millions of patients while advancing their careers in a high-growth MedTech environment. This role is suited for candidates who seek broad responsibility and exposure to the complete product lifecycle. Placement will be based on both experience and interest.

Key facts

What you'll do

• Design, prototype, and validate mechanical and mechatronic subsystems for surgical devices, ensuring performance and reliability targets are met.
• Develop detailed 3D CAD models, drawings, and assemblies with an emphasis on performance, reliability, and manufacturability for surgical instruments.
• Select materials and components suitable for precision, miniaturized mechanisms under medical device constraints and regulatory expectations.
• Conduct hands-on testing and experimentation to characterize performance and guide iterative design decisions in a fast-paced setting.
• Collaborate closely with manufacturing to optimize designs for manufacturability, assembly efficiency, and cost targets.
• Support design transfer activities to ensure smooth progression from prototype to production scale with robust documentation.
• Document development activities in accordance with medical device requirements, including design history records, test records, and traceability matrices.
• Drive continuous improvement initiatives for existing products, targeting quality enhancements, speed to market, and cost optimization.
• Partner with cross-functional teams to translate clinical needs into technical specifications and mechanical solutions.
• Evaluate emerging manufacturing techniques and integrate suitable processes into development workflows.
• Define test protocols and acceptance criteria to verify that mechanical systems meet functional and safety requirements.
• Maintain organized records of experiments, results, and design changes to support audits and regulatory submissions.
• Contribute to risk management processes by identifying potential failure modes and implementing mitigation strategies.
• Support the development of technical documentation and internal deliverables that enable smooth product commercialization.

Requirements

• Hold a B.S. in Mechanical Engineering or equivalent degree with strong foundational knowledge in core engineering disciplines.
• Demonstrate hands-on problem-solving skills and a solid grasp of mechanical engineering fundamentals, including mechanics, materials, and dynamics.
• Show proficiency in 3D CAD software, with a preference for SolidWorks, to create robust and manufacturable designs.
• Bring direct experience designing precision mechanical components that meet tight tolerances and performance criteria.
• Exhibit familiarity with manufacturing processes relevant to medical devices, including molding, machining, additive methods, and stamping.
• Maintain a mindset characterized by curiosity, ownership, and the ability to thrive in a fast-paced, collaborative, and regulated environment.
• Prior medical device experience is a plus but not a requirement for this role.
• Commit to working in an onsite role at the Bedford, Massachusetts location as practical notes specify this arrangement.
• Be prepared to submit a portfolio demonstrating relevant engineering projects alongside your application.
• Apply tools and methods consistent with quality systems and design controls expected in medical device development.

Nice to have

• Experience with surgical stapling hardware or similar procedural devices.
• Knowledge of design for assembly (DFA) principles specific to medical devices.
• Exposure to design validation within regulated environments.
• Understanding of statistical methods for process characterization and control.
• Familiarity with risk management standards such as ISO 14971 or related frameworks.

Practical notes

-

Location: Bedford, Massachusetts (near Boston). This is an onsite role.

-

Compensation: The target range for this position is $130,000-$160,000 Year of Experience, commensurate with background.

• Portfolio: Applicants must submit a portfolio demonstrating relevant engineering projects. This may include CAD work, prototypes, technical documentation, or other examples of engineering experience. Academic projects are acceptable.
• Tools: Proficiency in SolidWorks is required.
• Note: Details regarding requirements and daily activities should be confirmed on the official application page.