Sr. Principal, Mechanical Engineering (On-site)

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview

Insulet is seeking a highly skilled and motivated Principal Mechanical Engineer to play a critical role in the development of innovative, high-volume electromechanical medical devices. As a technical leader within the team, you will collaborate across disciplines to drive the design, development, and validation of next-generation platforms, ensuring they meet rigorous quality, performance, and manufacturability standards. The ideal candidate will have extensive experience in mechanical engineering for medical device development (Class II/III), a strong understanding of design for manufacturability, and a track record of delivering complex systems from concept to production.

Responsibilities

• Assume the role as subject matter expert (SME) for electro-mechanical systems and subassemblies for the creation of next-generation insulin delivery technologies (inclusive of ideation, design and filing of intellectual property)
• Lead the technical design and development of Class II/III medical devices, focusing on scalability, cost-effectiveness,  and high-volume manufacturing
• Advise the engineering team on the application of rigorous component, subsystem and system evaluation using first principles thinking and engineering analysis tools such as FEA, tolerance simulations and other statistical methods
• Mentor and provide technical guidance to junior engineers, fostering a culture of innovation and excellence
• Support the Director of Hardware in driving engineering roadmaps and executing strategic initiatives
• Design and prototype electro-mechanical device systems and subsystems using CAD software, rapid prototyping and testing equipment and supporting full system integration efforts
• Translate customer needs into engineering requirements for detailed product, packaging and process specifications
• Drive design reviews, risk assessments, and FMEA to ensure robust and reliable product performance
• Mentor other engineering team members within the organization
• Support the Director of Next Generation Platforms in driving engineering roadmaps and executing strategic initiatives
• Document and write detailed technical reports based on design verification analysis testing for all engineering activities
• Ensure compliance to Insulet quality policies as well as with all local, state, federal and Insulet safety regulations, policies and procedures

Required Skills and Competencies

• Natural out-of-the-box thinker who is driven to find novel solutions to challenging problems
• Ethical, responsible, and data-driven decision-maker
• Strong understanding of material science as it pertains to polymers, metals and glass
• Ability to effectively communicate (verbal/written) within engineering team
• Advanced CAD capabilities - complex assemblies, surfacing and multi-body modeling experience
• Ability to organize and judge priorities, as well as oversee and delegate responsibilities to other engineering staff / team members, when necessary
• Familiarity with SPC, GD&T, IQ/OQ/PQ, TMV, Lean and Six Sigma
• Knowledge of infusion pumps and subcutaneous injection systems, a plus
• PC skills - MS Office Suite, SolidWorks, and ePDM and advanced FEA analysis; LabVIEW, a plus
• Knowledge of Design for Manufacturing/Cost (DFM/C) and automated assembly experience
• Must be able to work cross-functionally with Systems, Quality, Manufacturing, Molding and Hardware engineering groups

Education and Experience

• Bachelor of Science in Mechanical Engineering or Biomedical Engineering. Master’s Degree Preferred
• 10+ years of electromechanical product design and development experience, preferably medical device class II or III 
• Proven expertise in designing electromechanical systems for high-volume production
• Strong und