Senior Manufacturing Engineer (On-site)

The Senior Manufacturing Engineer will work on-site to drive product and process improvements, support equipment validation and continuous improvement activities, and develop and drive continuous improvement efforts. The candidate will build and apply knowledge of Omnipod product function and manufacturing assembly processes to coordinate with equipment suppliers, CM counterparts, and various teams within Insulet to ensure the successful validation and performance of new and existing manufacturing equipment and processes.

Requirements

• Drive product and process improvements in support of Insulet's Operations (3) main objectives
• Project deliverables for installation of new manufacturing equipment and manufacturing equipment upgrades
• Support equipment validation and continuous improvement activities at Insulet manufacturing facilities
• Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support
• Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above target
• Develop and drive Continuous improvement efforts
• Generate validation/qualification (IQ, OQ, TMV, CSV, PQ) protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports
• Possesses strong mechanical analysis skills
• Analyze a product using mechanical engineering methods such as FBD analysis and fundamental physics
• Use standardized root cause investigation templates and problem-solving tools to carry out non-conforming material investigations
• Implement corrective and preventive actions
• 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
• At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing
• Author and implement Engineering Change Orders

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs