Sr. Mechanical Engineer, R&D (Onsite)

Insulet Corporation•Acton, MA

50d•Onsite

About The Position

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.

Requirements

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
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 components, a strong plus
Experience in the design of disposable, bio-compatible fluid paths and/or container solutions, a strong plus
Experience in high volume product design (>10 million units per year), a strong plus
A track record of generating novel ideas / IP, a strong plus

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