TM
Sr Mechanical R&D Engineer : Surgical Robotics : Thin Film Sterile Draping
Accepting applicationsThe Mullings Group · Greater Boston
Full-Time Mid_senior RF
Posted
3d ago
Category
Verification
Experience
Mid_senior
Country
N/A
Swan EndoSurgical
Senior Mechanical Design Engineer
Sterile Interface & Draping Systems
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 one of the most technically demanding and clinically critical subsystems on the robot: the sterile interface and thin film draping system. This is the boundary between the sterile field and the non-sterile capital equipment, and it must perform flawlessly every single case.
This is a hands-on design ownership role. You will take the sterile barrier architecture 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 the sterile drape system and sterile adapter interface for the surgical robotic platform, including thin film components, molded interface elements, and attachment features
- Design for the realities of the OR: fast and intuitive draping workflows, robust sterile barrier integrity, tactile and visual confirmation of correct installation, and tolerance for real-world handling
- Select and characterize thin film materials, evaluating weldability, drape and conformability, puncture and tear resistance, optical clarity, and compatibility with sterilization modalities
- Develop and manage relationships with converters and drape manufacturers, including process development for heat sealing, RF welding, die cutting, and film forming
- Own tolerance analysis and dimensional stack-ups across the sterile and non-sterile interface, ensuring reliable engagement of drive couplings, electrical pass-throughs, and instrument interfaces through the barrier
- Build prototypes, design and execute test methods, and lead design verification activities including barrier integrity, installation 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 surgical staff to refine draping workflow
What You Bring
- BS in Mechanical Engineering (BSME)
- 3+ years of mechanical design experience in medical devices, with significant time on sterile, single-use, or disposable components
- 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
Big Big Plus:
>Thin film or flexible material product design for sterile single-use devices. Hands-on design ownership of products made from thin film or flexible polymer materials (polyethylene, polyurethane, PVC, polyolefin) used in sterile environments, such as surgical drapes, sterile barriers, covers, pouches, or flexible disposables.
>Direct experience developing or specifying processes that turn film into product: heat sealing, RF welding, ultrasonic welding, thermoforming, or die cutting, including working with converters or contract manufacturers on process development.
>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
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Senior Mechanical Design Engineer
Sterile Interface & Draping Systems
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 one of the most technically demanding and clinically critical subsystems on the robot: the sterile interface and thin film draping system. This is the boundary between the sterile field and the non-sterile capital equipment, and it must perform flawlessly every single case.
This is a hands-on design ownership role. You will take the sterile barrier architecture 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 the sterile drape system and sterile adapter interface for the surgical robotic platform, including thin film components, molded interface elements, and attachment features
- Design for the realities of the OR: fast and intuitive draping workflows, robust sterile barrier integrity, tactile and visual confirmation of correct installation, and tolerance for real-world handling
- Select and characterize thin film materials, evaluating weldability, drape and conformability, puncture and tear resistance, optical clarity, and compatibility with sterilization modalities
- Develop and manage relationships with converters and drape manufacturers, including process development for heat sealing, RF welding, die cutting, and film forming
- Own tolerance analysis and dimensional stack-ups across the sterile and non-sterile interface, ensuring reliable engagement of drive couplings, electrical pass-throughs, and instrument interfaces through the barrier
- Build prototypes, design and execute test methods, and lead design verification activities including barrier integrity, installation 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 surgical staff to refine draping workflow
What You Bring
- BS in Mechanical Engineering (BSME)
- 3+ years of mechanical design experience in medical devices, with significant time on sterile, single-use, or disposable components
- 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
Big Big Plus:
>Thin film or flexible material product design for sterile single-use devices. Hands-on design ownership of products made from thin film or flexible polymer materials (polyethylene, polyurethane, PVC, polyolefin) used in sterile environments, such as surgical drapes, sterile barriers, covers, pouches, or flexible disposables.
>Direct experience developing or specifying processes that turn film into product: heat sealing, RF welding, ultrasonic welding, thermoforming, or die cutting, including working with converters or contract manufacturers on process development.
>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
Show more Show less