Insulet started in 2000 with an idea and a mission to enable 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 by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
Job Posting Title: Mechanical Engineer- MFG (JG6)
Job Description Summary
Position Overview:
We are looking for a self-motivated Mechanical Engineer to join the IMY Manufacturing team. This position will be responsible for working with team members on identifying and implementing improvement projects to support our IMY manufacturing operations. Additionally, this position will be highly engaged in leading root cause analysis of product failures to identify appropriate improvements and make them actionable. The person in this position will also be required to design, execute and report on engineering tests, for both feasibility and product verification. The candidate must have a strong engineering background with the ability to quickly understand electro-mechanical assemblies and a track record of delivering results on cross functional development and project teams. The optimum candidate has a BS in Mechanical Engineering or related discipline.
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.
Education and Experience:
Minimum Requirements:
• Bachelor's of Science in Mechanical Engineering or related field
• At least one year of working experience in related industry
Preferred Skills & Competencies:
• 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.
Physical Requirements:
• Domestic and international travel may be required up to 10% of the time.
• Ability to work with other team members in non-production hour (such as Sunday Maintenance or Engineering Build) in necessary