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.

Position Overview:

We are looking for a self-motivated Mechanical Engineer to join the Lifecycle/Sustaining Engineering team responsible for sustaining and implementing breakthrough improvements to on market products. Additionally, this position will be highly engaged in leading root cause analysis of product failures and customer complaints in order to identify appropriate improvements. This position will be integral in supporting and/or leading project teams to improve quality, reduce cost, and improve supply chain stability. 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 Ideal candidate will have experience with precision component manufacturing for high-volume assembled devices including precision plastics, metal stampings and screw machining.

Responsibilities

· Design iterations of existing 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, consultants, experts, as needed

· Review documents and engineering change orders and maintain documentation control prior to release.

· Travel overnight(s) as necessary both domestically and internationally to support project goals.

· Liaison cross functionally with stakeholders to drive alignment with project goals.

Required Leadership/Interpersonal Skills & Behaviors

· Provide leadership through positive motivation, guidance, and open communication.

Education and Experience

·Minimum Requirements:

o Bachelor of Science in Engineering

o 2 years of work experience in a regulated industry

o Demonstrated application/experience with SolidWorks or Creo

· Preferred Skills and Competencies:

o Masters degree a plus.

o Work experience in medical device design and development related to insulin and/or drug delivery systems.

o Experience with design verification and validation and engineering study design

o Experience with component design and material selection

o Working knowledge of Computer Aided Design & Finite Element Analysis. Advanced knowledge a plus

o Statistical Analysis (t-test, tolerance interval, confidence interval, ANOVA). Familiar with Minitab and/or JMP.

o Experience with organized root cause analysis (5 whys, is/is not, Ishikawa, etc)

o Experience with formal Risk Management tools including Preliminary Hazard Analysis (PHA), System Hazard Analysis (SHA) and Failure Mode and Effect Analysis (FMEA).

o Experience with projects involving domestic and international regulatory submissions.

o Experience leading engineering projects with basic project management skills (advanced skills a plus)

o 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)

o 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.

o Working knowledge of medical device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).

o Ability to learn and adapt quickly in a fast-paced dynamic environment

o Ability to identify, organize, and judge priorities and make recommendations to management.

o Ability to present and communicate clearly and confidently to multiple levels of an organization.

Additional Information

· The position is in-person at our Acton Facility

· Travel is estimated at 5% but will flex depending on business need.

Additional Information:

The US base salary range for this full-time position is $69,800.00 - $104,900.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.