Senior Mechanical Engineer (Onsite)

We are looking for a self-motivated Senior 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 involved in leading root cause analysis of product failures and customer complaints to identify appropriate improvements. This position will be integral in supporting and/or leading project teams to improve quality, reduce costs, 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 significant experience with precision component manufacturing for high-volume assembled devices including precision plastics, metal stampings, screw manufacturing, and packaging design. The ideal candidate additionally has experience working with suppliers of custom precision components for use in medical devices, automotive, or another highly regulated industry. 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. Education and Experience Minimum Requirements: Bachelor of Science in Mechanical Engineering or related field. Minimum of 5 years' work experience, preferably in device design and development in a regulated industry. Preferred Skills and Competencies: Master's degree a plus. 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). Experience with projects involving domestic and international regulatory submissions. 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 leading engineering projects 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. Experience with CAPA is a plus Experience in a project leadership role 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. NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite Additional Information: The US base salary range for this full-time position is $96,150.00 - $144,225.00. 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. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. 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! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights) Insulet Corporation is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights) Insulet employees are all focused on the same goal to make a difference. Our relentless passion is to simplify life for people with diabetes. We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance. We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there. We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers. Our innovation spirit and customer-centric focus position us as global pioneers leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.