Manager, Manufacturing Engineering

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