Senior Mechanical Design Engineer Electro-Mechanical Systems : Plastic Parts Design : Medical Device

The Mullings Group; Massachusetts; Hybrid; USD 110,000 - 170,000; Full time

Job summary

Swan EndoSurgical in Canton, MA is seeking a Senior Mechanical Design Engineer to own critical subsystems on a next-generation surgical robotic platform, spanning electro-mechanical assemblies and plastic component design. This hands-on role covers interfaces between capital equipment, instruments, and disposable components.

You will take subsystems from concept through design freeze, verification, and transfer to manufacturing, working with robotics, instrument, and clinical engineering teams

Qualifications

• BS in Mechanical Engineering (BSME).
• 3+ years of medical device mechanical design with electro-mechanical and plastics.
• Proficient in SolidWorks; GD&T and tolerance analysis.

Responsibilities

• Lead mechanical design of electro-mechanical subsystems for the surgical platform.
• Design plastic and polymer components with molding considerations.
• Own tolerance analysis and dimensional stack-ups across interfaces.
• Select materials for manufacturability and sterilization compatibility.
• Collaborate with suppliers and contract manufacturers for molding and machining.
• Build prototypes, run tests, and lead verification activities.
• Prepare DHF documentation and risk analysis per ISO 13485 and FDA 21 CFR 820.
• Support usability studies to refine product design.

Skills

CAD proficiency

GD&T & tolerance analysis

Medical device design

Electro-mechanical systems

Plastic component design

Design controls

DHF documentation & verification

Design transfer leadership

Education

BS in Mechanical Engineering

Tools

SolidWorks

Job description

Electro-Mechanical Systems : Plastic Parts Design : Medical Device

Canton, MA : Hybrid / Onsite

About the Opportunity

Swan EndoSurgical is developing a next-generation surgical robotic platform, and we are seeking a Senior Mechanical Design Engineer to own critical mechanical subsystems on the robot, spanning electro-mechanical assemblies, precision mechanisms, and plastic/polymer component design. This is a hands-on design ownership role covering the interfaces between capital equipment, instruments, and disposable components.

You will take subsystems from concept through design freeze, verification, and transfer to manufacturing, working shoulder to shoulder with robotics, instrument, and clinical engineering teams in our Canton office.

What You Will Do

• Lead mechanical design and development of electro-mechanical subsystems for the surgical robotic platform, including precision mechanisms, drive interfaces, and instrument attachment features
• Design plastic and polymer components across the platform, from structural housings to molded interface elements, applying sound plastic part design principles (draft, wall thickness, gate location, tooling considerations)
• Own tolerance analysis and dimensional stack-ups across mechanical and electro-mechanical interfaces, ensuring reliable engagement of drive couplings, electrical pass-throughs, and instrument interfaces
• Select and characterize materials (metals, engineering plastics, and where relevant, flexible films) for manufacturability, mechanical performance, and compatibility with sterilization modalities
• Develop and manage relationships with suppliers and contract manufacturers, including process development for injection molding, machining, and where applicable, film converting or joining processes
• Build prototypes, design and execute test methods, and lead design verification activities including functional performance, usability, and lifecycle testing
• Author design history file documentation including requirements, risk analysis inputs (dFMEA), drawings, and specifications under design control per ISO 13485 and FDA 21 CFR 820
• Support usability engineering activities and formative studies with end users to refine product design

What You Bring

• BS in Mechanical Engineering (BSME)
• 3+ years of mechanical design experience in medical devices, with exposure to electro-mechanical systems and plastic/polymer component design
• Strong CAD proficiency (SolidWorks preferred) and command of GD&T and tolerance analysis
• Experience designing under formal design controls in a regulated environment
• Demonstrated ability to take a subsystem from concept through verification and manufacturing transfer
• Experience designing plastic or polymer components for medical devices, including injection molded parts, housings, or single-use/disposable products, with an understanding of moldability and manufacturing constraints
• Direct experience with electro-mechanical system design, including motors, drive couplings, sensors, or actuation mechanisms integrated into a capital equipment platform
• Demonstrated ability to carry a component or subsystem from concept through verification and manufacturing transfer under ISO 13485 and FDA 21 CFR 820, including authoring DHF documentation and leading design verification testing