Manager, Manufacturing Engineering

Job Summary Job Title: Manager, Manufacturing Engineering Department: Global Manufacturing Engineering FLSA Status: Exempt Position Overview: The Manager, Manufacturing Engineering is a critical lead member of the Global Manufacturing Engineering team supporting the day to day activities of the Operations and Manufacturing Engineering Group. This leader is the owner of key automation equipment used to produce Insulet products. The individual will have around 6-8 Manufacturing Engineers reporting to them. This leader is responsible for KPIs for machine up time, process yield and efficiency for his/her group of automation equipment, in addition to managing and executing other manufacturing projects. Projects may include cost and quality improvements, line qualifications, new product introductions (NPI) and other as assigned by manager. As part of providing support to the Operations and Manufacturing 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: • Manager of Manufacturing Engineers responsible for performance and sustainability of automation equipment • All reporting / performance tracking requirements for their respective Cells • Drive product and process improvements in support of Insulet’s Operations (4) main objectives o Best Quality o Highest Efficiency o Highest Customer Service o Lowest cost • Develop and drive Continuous improvement efforts. • Manage Insulet Automation suppliers and deliver new machines and machine improvements • At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing. • Generate validation/qualification protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports • Author and implement Engineering Change Orders • Design and coordinate the construction and validation of manufacturing fixtures • Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support. • Use standardized root cause investigation templates and problem solving tools to carry out non-conforming material investigations • Implement corrective and preventive actions • Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above target • Support new product introduction initiatives • Travel to key suppliers to help them carry out critical investigations or improvement projects • Carry out duties in a quality system environment • Possesses strong mechanical analysis skills • Analyze a product using mechanical engineering methods such as FBD analysis and fundamental physics. • Interpret the mechanical properties of the selected material for the product design and make recommendations for suitable alternatives. • Performs other duties as required Education and Experience: Minimum Requirements: • B.S. in Mechanical Engineering and 10+ years of medical device, or similar, experience • M.S. in Mechanical/Industrial or Engineering Management with 8 plus years of experience Preferred Skills and Competencies: • Proficient in all Microsoft Office tools • Excellent Microsoft Excel and Data Analysis Skills – Minitab of JMP • Proficient in Solidworks and drafting skills • Comfortable troubleshooting mechanical equipment both Semi and fully automated • Basic knowledge of common challenges with assembly of molded components required • Strong command of structured problem solving tools • Excellent project management skills • 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 (if applicable): • 10% to 25% travel required, mostly international (Canada & China) Job Title: Manager, Manufacturing Engineering (Onsite) Department: Global Manufacturing Engineering FLSA Status: Exempt Company Overview Insulet started in 2000 driven to achieve our mission of enabling 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 who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe. We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it. Position Overview The Manager, Manufacturing Engineering is a critical lead member of the Global Manufacturing Engineering team supporting the day to day activities of the Operations and Manufacturing Engineering Group. This leader is the owner of key automation equipment used to produce Insulet products. The individual will have around 6-8 Manufacturing Engineers reporting to them. This leader is responsible for KPIs for machine up time, process yield and efficiency for his/her group of automation equipment, in addition to managing and executing other manufacturing projects. Projects may include cost and quality improvements, line qualifications, new product introductions (NPI) and other as assigned by manager. As part of providing support to the Operations and Manufacturing 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 Manager of Manufacturing Engineers responsible for performance and sustainability of automation equipment All reporting / performance tracking requirements for their respective Cells Drive product and process improvements in support of Insulet’s Operations (4) main objectives Best Quality Highest Efficiency Highest Customer Service Lowest cost Develop and drive Continuous improvement efforts. Manage Insulet Automation suppliers and deliver new machines and machine improvements At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing. Generate validation/qualification protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports Author and implement Engineering Change Orders Design and coordinate the construction and validation of manufacturing fixtures Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support. Use standardized root cause investigation templates and problem solving tools to carry out non-conforming material investigations Implement corrective and preventive actions Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above target Support new product introduction initiatives Travel to key suppliers to help them carry out critical investigations or improvement projects Carry out duties in a quality system environment Possesses strong mechanical analysis skills Analyze a product using mechanical engineering methods such as FBD analysis and fundamental physics. Interpret the mechanical properties of the selected material for the product design and make recommendations for suitable alternatives. Performs other duties as required Required Leadership/Interpersonal Skills & Behaviors Team Development: Build capability through coaching and mentoring. Strategic Thinking: Align engineering priorities with business objectives. Influence & Collaboration: Drive cross-functional improvements and resolve conflicts constructively. Accountability: Set clear expectations and deliver results. Change Leadership: Champion continuous improvement and adaptability. Preferred Skills and Competencies: Proficient in all Microsoft Office tools Excellent Microsoft Excel and Data Analysis Skills – Minitab of JMP Proficient in Solidworks and drafting skills Comfortable troubleshooting mechanical equipment both Semi and fully automated Basic knowledge of common challenges with assembly of molded components required Strong command of structured problem solving tools Excellent project management skills 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. Education and Experience B.S. in Mechanical Engineering and 10+ years of medical device, or similar, experience M.S. in Mechanical/Industrial or Engineering Management with 8 plus years of experience Minimum of one year of experience leading and managing employees Additional Information 30% to 40% travel required, mostly international NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $122,600.00 - $183,950.00 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) 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.