Director, Advance Manufacturing Engineering (Onsite)

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

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 Director of Advanced Manufacturing Engineering will lead the development and execution of next-generation manufacturing technologies for a high-volume, fully automated medical device production & operations. This role is pivotal in shaping the future of manufacturing at scale, driving innovation in automation, tooling, metrology, inline testing for the pod manufacturing process and in the supplier component tooling for injection molding and stamping. The successful candidate will build and lead a high-performing engineering team focused on concept generation, quality improvement, manufacturing design excellence, and operational efficiency. 

Key Responsibilities

Strategic Leadership 

• Build and lead a world-class Advanced Manufacturing Engineering (AME) cross- functional team with disciplines in MFG Engineering, Machine Design & Controls engineering. 

• Define and execute the vision for next-generation automation and manufacturing technologies 

• Collaborate cross-functionally with Global MFG Engineering, Operations, Quality, Supply Chain & R&D to ensure seamless design transfer and manufacturability 

Technology Innovation

• Drive concept development for advanced automation, tooling, metrology, and inline testing systems specifically focused on increased production speeds, improved inline inspections, and next generation feed systems. 

• Lead innovation in component tooling strategies for injection molding and stamping processes. 

• Champion the use of statistical modeling, systems thinking, and data analytics in engineering solutions. 

Process Development & Validation 

• innovation development with process validation improvements including IQ, OQ, TMV & PQ. 

• Ensure robust design for manufacturing (DFM) and process scalability across global sites. 

Operational Excellence 

• Establish KPIs and drive manufacturing performance improvements aligned with business goals. 

• Ensure compliance with regulatory standards and quality systems (e.g., FDA, ISO 13485). 

Global Collaboration 

• Provide technical leadership and support to global automation partnerships in the development of next generation manufacturing systems. 

Required Skills and Competencies

• Proven track record of building and leading high-performing engineering teams. 

• Expertise in automation, tooling design, metrology, inline testing, and component tooling (injection molding & stamping). 

• Excellent leadership and project management skills. 

• Exceptional communication and stakeholder management skills, with experience presenting to executive leadership.

Preferred / Nice to Have

• Experience with FDA regulations and related medical device regulatory frameworks and strong understanding of regulatory requirements (e.g., FDA, ISO 13485). 
• Deep understanding of medical device manufacturing processes and associated regulatory considerations.

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