Senior Manufacturing Engineer, Test & Controls

Job Profile Title: Sr. Manufacturing Engineer 

Business Title: Sr. Manufacturing Engineer, Test & Controls 

Position Overview: 

The Sr. Manufacturing Engineer, Test & Controls is a hands-on technical contributor responsible for developing, validating, and optimizing manufacturing test systems and processes for next-generation medical devices. This role emphasizes test development for low-power embedded electronics and analog/digital circuits, supporting pilot and production environments with robust, scalable, and compliant solutions. 

The engineer will collaborate cross-functionally with R&D (Electrical/Mechanical), Manufacturing, Software, Quality, and Systems teams to ensure test strategies align with product requirements and manufacturing capabilities. 

Note: This role will begin with a 3 to 6-month rotation through Insulet’s Global Manufacturing Engineering (GME) organization. During this time, the engineer will gain hands-on experience across multiple teams, build cross-functional relationships, and develop a strong understanding of Omnipod assembly and system-level function. After the rotation period, the engineer will transition into a dedicated NPI project team. 

Responsibilities: 

• Develop and implement manufacturing test strategies for pilot and production lines, focusing on low-power embedded systems and analog/digital circuits. 

• Design, source, and validate custom test fixtures and automated test systems. 

• Collaborate with Electrical Engineering to define test requirements and ensure design for testability (DFT). 

• Author and execute test protocols and validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), in compliance with FDA regulations and ISO 13485 standards. 

• Troubleshoot and resolve test-related issues on the manufacturing floor, including product hardware, software, and test system performance. 

• Support process verification, validation, and documentation for new and existing products. 

• Apply principles of electrical and system design to analyze failures and drive improvements in test and manufacturing processes. 

• Support risk management, usability studies, and design validation processes. 

• Interface with internal and external resources to source and qualify test equipment and components. 

• Leverage data to drive problem resolution and continuous improvement. 

• Support integration of data collection systems for quality, productivity, and traceability. 

Key Decision Rights: 

• Technical lead for new product manufacturing test strategy, design, setup, validation, and equipment/vendor selection. 

• Influence manufacturing test development and capacity expansion planning.