Sr. Mechanical Engineer, R&D (Onsite)

Position Overview:

Insulet is looking for a Sr. Mechanical Engineer to help drive innovation and leadership within its design team. The Sr. Mechanical Engineer is responsible for driving design and development of Insulet’s next generation wearables and platform extensions.  To accomplish this, the Sr. Mechanical Engineer applies a first principles approach and quickly works to prove feasibility on device subsystems, rapidly prototype integrated systems, optimizing new devices for manufacturability, and ultimately supporting design transfer of a commercial-ready product into a highly automated production environment.  Success depends on a strong understanding of engineering and scientific fundamentals as well as experience with end-to-end product design in the medical device environment.  This is a challenging role, suitable for an energetic problem solver who thrives on difficult technical challenges and who wishes to work on a small team charged with developing solutions to hard problems.

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 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

• 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

• Identify and mitigate risks associated with device functionality, reliability, safety, COGs and manufacturing scalability

• Design, setup and execute or guide feasibility tests 

• Work with cross-functional teams within the organization 

• Work within a final assembly manufacturing environment(s) and assist in early-stage process development and manufacturing optimization to ensure products meet design intent 

• Work with and manage external suppliers, conduct DFM reviews, and go onsite as needed 

• Conduct competitor technology tear-down studies

• Develop failure analysis models using simulation tools

• Participate in strategic planning activities   

• Mentor other engineering team members within the organization

• 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 procedure

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

• Knowledgeable in the design and joining of plastic components for bio-compatible applications

• 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 and TMV; Lean, Six Sigma, a plus

• Knowledge of infusion pumps and subcutaneous injection systems, a plus

• PC skills - MS Office Suite, SolidWorks, and ePDM required. Ansys, LabVIEW, a plus

• Knowledge of Design for manufacturing/cost (DFM/C) and automated assembly experience, a plus

• 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

• Minimum of 6 years of electromechanical product design and development experience, preferably medical device class II or III

• Experience in the design of injection molded components, stampings and machined co