Associate Mechanical Engineer (Onsite)

Insulet Corporation•Acton, MA

1d•Onsite

About The Position

Position Overview: We are looking for a self-motivated Associate Mechanical Engineer to join the US Manufacturing team. This is an entry level position in which the individual will be responsible for working with team members on identifying and implementing improvement projects to support our US 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.

Requirements

Bachelors of Science in Mechanical Engineering or related field.

Nice To Haves

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.

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.