Senior Manufacturing Engineer (Onsite - Acton, MA)

Job SummaryThis Senior Manufacturing Engineer role is responsible for supporting both new manufacturing line/equipment implementation and continuous improvement of existing production processes for Insulet’s Omnipod products. The position focuses on driving manufacturing excellence through improved quality, efficiency, and cost reduction while leading equipment validation, troubleshooting, root cause investigations, and process optimization activities. Working closely with suppliers, contract manufacturers, and cross-functional teams, the engineer will manage projects from concept through production, monitor key performance metrics such as yield and equipment uptime, and ensure compliance with medical device quality and regulatory requirements. The ideal candidate has a strong engineering background, experience in medical device manufacturing, expertise in automation and process improvement, and a passion for solving complex manufacturing challenges in a highly regulated environment. Job Title: Senior Manufacturing EngineerFLAS Status: ExemptPosition Overview: The candidate will work both on the addition of new manufacturing lines and equipment, as well as continuous improvement efforts for existing manufacturing processes/equipment.The candidate will build and apply knowledge of Omnipod product function and manufacturing assembly processes to coordinate with equipment suppliers, CM counterparts, and various teams within Insulet to ensure the successful validation and performance of new and existing manufacturing equipment and processes.The candidate will be responsible for KPIs for project budget and timing, as well as machine up-time, process yield and efficiency once equipment is in production.As part of providing support to the Global Manufacturing Engineering Group, the candidate will also carry out root cause investigations using structured problem-solving tools and will author and review quality system documentation such as validations, work instructions, SOPs, non-conforming material investigations, and tool files. Responsibilities:Drive product and process improvements in support of Insulet’s Operations (3) main objectivesBest QualityHighest EfficiencyLowest costProject deliverables for installation of new manufacturing equipment and manufacturing equipment upgradesSupport equipment validation and continuous improvement activities at Insulet manufacturing facilitiesSupport responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support.Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above targetDevelop and drive Continuous improvement efforts.Generate validation/qualification (IQ, OQ, TMV, CSV, PQ) protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reportsPossesses strong mechanical analysis skillsAnalyze a product using mechanical engineering methods such as FBD analysis and fundamental physics.Use standardized root cause investigation templates and problem-solving tools to carry out non-conforming material investigationsImplement corrective and preventive actionsSupport new product introduction initiativesTravel to key suppliers to help them carry out critical investigations or improvement projectsCarry out duties in a quality system environmentAt all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing.Author and implement Engineering Change OrdersUp to 5% travel required, ability to travel internationallyPerforms other duties as requiredSkills/Competencies:Proficient in all Microsoft Office toolsExcellent Microsoft Excel and Data Analysis SkillsWorking knowledge of Minitab and/or JMP statistical analysis softwareWorking Knowledge of Solidworks and print readingProficient in Six Sigma/Lean manufacturing conceptsComfortable troubleshooting mechanical equipment both Semi and fully automatedBasic knowledge of common challenges with assembly of molded components, stamped metal, and springsStrong command of structured problem-solving toolsStrong project management skillsBehavioral Competencies:Decision Making – has a systematic and methodical approach to making decisions, seeks out and explores relevant information, thinks creatively beyond the immediate problem, assimilates facts quickly, challenges assumptions, and considers business implications of potential solutions.Communication Skills – Conveys information effectively, actively listens, resolves conflict constructively.Work Organization – Takes a structured, economical approach to resources including time, people, money, and equipment.Problem Solving – Uses a systematic, methodical approach to gather facts, define problems, generate and implement solutions.Initiative – Makes decisions and takes actions appropriately. Willing to take risks as circumstances require.Planning Skills – Sets goals and priorities, thinks ahead, identifies activities and resources needed to achieve goals.Perseverance – Achieves objectives by overcoming difficulties through tenacity and resilience.Physical Requirements: Able to work in Class 8 Cleanroom Environment for extended time in a standing positionEducation and Experience:BS. in Mechanical/Industrial/Electrical Engineering and 6+ years of medical device experience; preferably in a manufacturing environmentMS. in Mechanical/Industrial/Electrical or Engineering Management with 5+ years of medical device experience; preferably in a manufacturing environmentNOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-OnsiteAdditional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $94,700.00 - $142,100.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including:

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs

Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.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)SummaryLocation: Acton, MassachusettsType: Full time