Staff Manufacturing Engineer (Onsite)

Position Overview: 

The Staff Manufacturing Engineer – New Product Introduction (NPI) is a senior-level individual contributor focused on the hands-on development, troubleshooting, and optimization of manual and semi-automated assembly processes for next-generation products. Working directly on the manufacturing floor, this role is responsible for ensuring that pilot production lines are capable, efficient, and ready to support early builds and design validation. The Staff Engineer will lead efforts to resolve real-time process issues, validate new equipment, and implement improvements that enhance product quality and manufacturability. This role will also interface with equipment vendors and internal design teams to source, fabricate, and set up custom assembly fixtures and equipment. A key responsibility is to gather and transfer process knowledge and lessons learned from the pilot line to support the design and development of fully automated production systems. This role is critical to ensuring Insulet’s future products are launched with robust, scalable, and high-quality manufacturing processes. 

Responsibilities: 

• Serve as the technical lead for pilot manufacturing line setup, validation, and readiness for new product introductions 

• Lead the installation, configuration, and optimization of manual and semi-automated assembly equipment to support early-stage builds 

• Interface with equipment vendors and internal design resources to source, fabricate, and implement custom assembly fixtures and tooling 

• Execute and document equipment and process validations (IQ, OQ, PQ, TMV, CSV) in compliance with regulatory and quality standards 

• Troubleshoot and resolve real-time issues on the manufacturing floor related to equipment, tooling, and process performance 

• Drive continuous improvement of pilot line processes to enhance yield, cycle time, quality, and efficiency 

• Monitor and report on key performance indicators (KPIs) such as process yield, equipment uptime, and line efficiency 

• Collaborate with cross-functional teams to ensure smooth knowledge transfer from pilot line to automation development teams 

• Support DFM/DFA activities by providing feedback to R&D based on pilot line performance and manufacturability observations 

• Lead structured root cause investigations and implement corrective and preventive actions (CAPAs) for process deviations and non-conformances 

• Author and maintain quality system documentation including work instructions, SOPs, non-conforming material reports, and Engineering Change Orders (ECOs) 

• Ensure all work complies with FDA regulations, ISO 13485, GMP, and internal quality standards 

Key Decision Rights: 

• Technical lead for NPI manufacturing process design, setup, validation strategy, and equipment selection. 

• Influence manufacturing process evolution and capacity expansion planning. 

Required Leadership/Interpersonal Skills & Behaviors: 

• Skilled at anticipating technical challenges and aligning work with manufacturing needs 

• Strong communicator with the ability to collaborate effectively across teams 

• Demonstrated ability to make sound, data-driven decisions 

• Experience mentoring peers and promoting a culture of continuous improvement 

• Takes initiative to