Principal R&D Design Engineer : Surgical Instrumentation : Flexibile Endoscopic Devices

The Mullings Group; Boston (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

The Mullings Group in the Boston area is seeking a Mechanical Design Engineer to develop surgical instruments for robotic-assisted endoluminal procedures. You will balance clinical performance with robotic actuation constraints and miniaturization.

You will collaborate with surgeons, clinical advisors, and engineers to move concepts through validation, cadaver labs, and regulatory milestones, delivering a manufacturable toolkit for the platform.

Qualifications

• Bachelor's degree in Mechanical Engineering or related discipline (MS preferred for candidates with limited industry experience)
• 4-8 years of mechanical design engineering experience in surgical instrumentation, medical devices, or precision mechanisms requiring miniaturization and high reliability
• Direct experience designing surgical instruments, catheter-based devices, endoscopic tools, or other minimally invasive surgical devices with understanding of clinical workflow and surgical technique
• Proficiency in 3D CAD design using SolidWorks, Creo, NX, or similar platforms with demonstrated ability to design complex assemblies involving articulation mechanisms, cable-driven systems, and miniaturized components
• Strong understanding of materials selection for surgical instruments including stainless steel alloys, titanium, nitinol, engineering plastics, and biocompatible materials with consideration for mechanical properties, sterilization compatibility, and regulatory requirements
• Experience with engineering analysis including tolerance analysis, stress/fatigue analysis using FEA, and kinematic/dynamic modeling to validate mechanical designs for surgical applications
• Working knowledge of manufacturing processes relevant to surgical instruments including precision machining, tube fabrication, laser cutting/welding, wire EDM, cable systems, injection molding, and cleanroom assembly

Responsibilities

• Design surgical instruments for robotic-assisted endoluminal procedures, ensuring clinical performance and integration with the robotic actuation system.
• Create detailed CAD designs (SolidWorks/Creo/NX), emphasizing miniaturization and GD&T, with BOMs and manufacturing specs.
• Perform kinematic, stress, fatigue analyses and tolerance studies to validate designs per safety and performance specs.
• Collaborate with surgeons and experts to translate clinical needs into instrument design, participating in labs and usability studies.
• Collaborate with robotics and software teams to ensure tight integration with the robotic platform (actuation, sensors, control algorithms).
• Develop test protocols and perform mechanical testing (articulation, force, endurance, sterilization) to verify designs.
• Collaborate with manufacturers on prototypes and DFM for tube fabrication, laser/welding, wire EDM, cable/pulley systems, and molding.

Skills

Mechanical design

Surgical instrumentation

Robotic-assisted tools

CAD (SolidWorks/Creo/NX)

FEA

Manufacturing know-how

Education

Bachelor's degree in Mechanical Engineering

MS preferred

Tools

SolidWorks

Creo

NX

FEA tools

Job description

Surgical Instrumentation (Robotic-Assisted Endoluminal Platform)

Company Overview

A well-funded surgical robotics company in the Boston area is developing breakthrough robotic-assisted technology for endoluminal procedures. This venture-backed organization is advancing its surgical instrumentation portfolio designed to work seamlessly with its proprietary robotic platform, enabling minimally invasive interventions in complex anatomical spaces. With a world-class engineering team and strong institutional backing, the company is transitioning from early development to clinical validation and commercial readiness.

Position Overview

The Mechanical Design Engineer will focus on the design, development, and validation of surgical instruments specifically engineered for robotic-assisted endoluminal procedures. This role demands a mechanical engineer who can design highly specialized instruments that balance clinical performance requirements with the unique constraints of robotic actuation, miniaturization, and endoluminal navigation. The successful candidate will work onsite in the Boston area as part of a multidisciplinary R&D team bringing innovative surgical instrumentation from concept through regulatory submission and commercial launch.

The Opportunity

This position offers the rare opportunity to define the next generation of robotic-assisted surgical instruments for endoluminal applications. The Mechanical Design Engineer will be directly responsible for designing instruments that enable novel therapeutic interventions, working at the intersection of precision mechanism design, surgical workflow understanding, and robotic system integration.

Key Responsibilities:

• Design and develop surgical instruments for robotic-assisted endoluminal procedures including graspers, dissectors, energy devices, staplers, and specialized therapeutic tools, ensuring designs meet clinical performance requirements while integrating with the robotic actuation system, articulation mechanisms, and control architecture.
• Create detailed mechanical designs using SolidWorks or similar CAD platforms with emphasis on miniaturization, degrees of freedom optimization, force transmission efficiency, and geometric constraints imposed by endoluminal access pathways, producing engineering drawings with proper GD&T, BOMs, and manufacturing specifications.
• Conduct engineering analysis to validate instrument designs including kinematic modeling, stress analysis, fatigue evaluation, tolerance stack-ups, cable/tendon tension analysis, and articulation workspace assessment using FEA tools and analytical methods to ensure designs meet performance specifications and safety requirements.
• Collaborate with surgeons, clinical advisors, and human factors specialists to translate clinical needs into instrument design requirements, participating in cadaver labs, surgical observations, and usability studies to understand workflow, ergonomics, visualization needs, and therapeutic technique requirements.
• Work closely with robotics engineers, controls specialists, and software developers to ensure instrument designs integrate effectively with the robotic platform including actuation interfaces, sensor integration, force feedback systems, and control algorithms that enable precise manipulation.
• Support design verification and validation activities by developing test protocols, conducting mechanical testing (articulation range, force transmission, endurance, sterilization compatibility), analyzing results, troubleshooting failures, and implementing design improvements based on findings within design control frameworks.
• Partner with contract manufacturers, fabrication vendors, and suppliers to prototype surgical instruments, working through design-for-manufacturability considerations for processes including precision tube fabrication, laser cutting/welding, wire EDM, cable/pulley systems, injection molding of handles and actuators, and assembly techniques for miniaturized mechanisms

Impact in First 12-18 Months:

The successful Mechanical Design Engineer will have established themselves as the go-to expert on surgical instrument design for the robotic platform. Within the first year, you will have designed, prototyped, and validated multiple instruments that form the core therapeutic toolkit for the platform. Your designs will be evident in successful cadaver lab validations, positive surgeon feedback on instrument performance, and progress toward design freeze for regulatory submissions. You will have built strong relationships with clinical advisors who trust your ability to translate their needs into functional instruments, and with manufacturing partners who rely on your technical guidance.

Qualifications

Must-Have Qualifications:

• Bachelor's degree in Mechanical Engineering or related discipline (MS preferred for candidates with limited industry experience)
• 4-8 years of mechanical design engineering experience in surgical instrumentation, medical devices, or precision mechanisms requiring miniaturization and high reliability
• Direct experience designing surgical instruments, catheter-based devices, endoscopic tools, laparoscopic instruments, or other minimally invasive surgical devices with understanding of clinical workflow and surgical technique
• Proficiency in 3D CAD design using SolidWorks, Creo, NX, or similar platforms with demonstrated ability to design complex assemblies involving articulation mechanisms, cable-driven systems, and miniaturized components
• Strong understanding of materials selection for surgical instruments including stainless steel alloys, titanium, nitinol, engineering plastics, and biocompatible materials with consideration for mechanical properties, sterilization compatibility (autoclave, ethylene oxide, hydrogen peroxide), and regulatory requirements
• Experience with engineering analysis including tolerance analysis, stress/fatigue analysis using FEA, and kinematic/dynamic modeling to validate mechanical designs for surgical applications
• Working knowledge of manufacturing processes relevant to surgical instruments including precision machining, tube fabrication, laser cutting/welding, wire EDM, cable systems, injection molding, and cleanroom assembly

Preferred Qualifications:

• Background in catheter-based devices, endoluminal tools, or flexible instruments requiring navigation through tortuous anatomy with constraints on diameter, articulation range, and force transmission
• Familiarity with medical device design controls per FDA 21 CFR Part 820 and ISO 13485, including requirements management, risk management per ISO 14971, design history file documentation, and design verification/validation protocols
• Direct experience conducting cadaver lab studies, surgical observations, or usability testing to gather clinical feedback and validate instrument designs with surgeon end-users
• Understanding of human factors engineering and ergonomic design for handheld surgical instruments, actuation interfaces, and robotic teleoperation systems
• Exposure to sterilization validation, biocompatibility testing, and reusable instrument cleaning/reprocessing requirements for surgical devices