Associate Mechanical Engineer (Onsite) at Insulet… · US -…

Summary: Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. They are seeking a self-motivated Associate Mechanical Engineer to join their US Manufacturing team, responsible for implementing improvement projects and leading root cause analysis of product failures. The role also involves designing and executing engineering tests for product verification. Responsibilities: - Design iterations of existing materials or products to improve quality, service, and cost - Design and set up feasibility tests to evaluate concepts, new materials and components - Support/lead cross functional teams as a mechanical engineering representative and/or project leader depending on project scope - Develop/execute engineering project plans to burn down risks and optimize resource utilization - Lead and support root cause analysis for product failures and other issues - Author product qualifications test and report results - Design test fixtures for product qualification using CAD and/or other technologies - Interface with external suppliers, consultant, experts, as needed - Review documents and engineering change orders and maintain documentation control prior to release - Liaison cross functionally with stakeholders to drive alignment with project goals Required Qualifications: - Bachelors of Science in Mechanical Engineering or related field Preferred Qualifications: - Experience with design verification and validation and engineering study design - Experience with component design and material selection - Experience with organized root cause analysis (5 whys, is/is not, Ishikawa, etc) - Experience with formal Risk Management tools including Preliminary Hazard Analysis (PHA), System Hazard Analysis (SHA) and Failure Mode and Effect Analysis (FMEA) - Demonstrated excellent project team skills as part of a cross-functional team that includes development/procurement/manufacturing/regulatory and quality experts - Cross functional team leadership experience a plus - Experience with continuous improvement methods and toolsets such as Six Sigma, Kaizen, CTQ and Critical Parameter Management. Six Sigma Green Belt or Black Belt certification is a plus - Working knowledge of medical device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls) - Statistical Analysis (t-test, tolerance interval, confidence interval, ANOVA). Familiar with Minitab and/or JMP - Working knowledge of Computer Aided Design & Finite Element Analysis. Advanced knowledge a plus - Formalized problem solving (Cause and Effect, A3, 5 Whys8Ds, DMAIC, PDCA) - Ability to learn and adapt quickly in a fast paced dynamic environment - Ability to identify, organize, and judge priorities and make recommendations to management - Basic project management skills (advanced skills a plus) - Ability to communicate and collaborate within a cross functional project team - Ability to present and communicate clearly and confidently to multiple levels of an organization Required Skills: Mechanical Engineering, Design Verification, Root Cause Analysis, Risk Management Important Skills: Statistical Analysis, Computer Aided Design, Project Management Nice-to-Have Skills: Cross Functional Teamwork Benefits: Medical, dental, and vision insurance, 401(k) with company match, Paid time off (PTO), And additional employee wellness programs