Associate Mechanical Engineer (Onsite) at Insulet… · Massachus…

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 support US manufacturing operations by identifying and implementing improvement projects and leading root cause analysis of product failures. 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, Root Cause Analysis, Design Verification Important Skills: Six Sigma, Computer Aided Design, Statistical Analysis Nice-to-Have Skills: Project Management, Cross Functional Collaboration Benefits: Medical, dental, and vision insurance, 401(k) with company match, Paid time off (PTO), And additional employee wellness programs