Senior Manufacturing Engineer (781076)

Responsible for driving continuous improvement initiatives to enhance manufacturing operations, focusing on assigned equipment, processes, and systems to meet Insulet’s goals of Best Quality, Highest Efficiency, and Lowest Cost. Lead the installation, qualification, and validation of new manufacturing equipment, including developing and executing process validation protocols (IQ/OQ/PQ) and managing all associated documentation. Troubleshoot and resolve complex production issues related to material and method, working closely with cross-functional teams to maintain compliance with GMP and the company’s Quality Management System. Create and revise key manufacturing-related risk documents, such as Process FMEAs, manufacturing line specifications, and equipment specifications, while ensuring the effective identification of root causes for operational failures using problem-solving tools like Fishbone diagrams, 5 Whys, Pareto charts, and other investigative techniques. Lead Corrective and Preventive Action (CAPA) initiatives, analyzing production failures and implementing improvements to prevent recurrence. Establish performance metrics to track and monitor the efficiency of processes, equipment, and tools, ensuring that all KPIs (such as yield, equipment uptime, and production throughput) are met or exceeded. Initiate re-validations, conduct process improvements, and provide ongoing support to maintain product and process quality. Play an active role in supporting new product introductions (NPI), contributing to the smooth integration of new products into the manufacturing process. Conduct detailed root cause investigations, analyze non-conforming materials, and use data-driven methodologies such as PDCA, A3, and 8D to resolve quality issues. Oversee Capex projects by identifying systemic problems, performing cost-benefit analysis, and ensuring that process improvements are implemented within budget. Responsible for mentoring team members, providing training on troubleshooting, work instructions, and process improvement techniques, and working closely with suppliers on critical investigations or improvement projects.

Job Requirements:

Requires a Master’s degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, or a directly related field plus two (2) years of experience in a semi or full automated manufacturing environment. Experience must include:

One (1) year of experience in each of the following (experience may be gained concurrently):

- Using data-driven methodologies including PDCA, A3, and 8D to resolve quality issues and to lead continuous improvement projects

- Monitoring and reporting on yield and equipment up-time information, including owning the required efforts to ensure these KPIs are at or above target

- Creating and revising key manufacturing-related risk documents, including Process FMEAs, manufacturing line specifications, or equipment specifications

- Identifying of root causes for operational failures using problem-solving tools such as Fishbone diagrams, 5 Whys, or Pareto charts

- Supporting new product introduction initiatives

- Analyzing a product using mechanical engineering methods including FBD analysis or fundamental physics

- Data Analysis using Minitab or JMP

- Identifying equipment problem areas and proposing solutions

Will accept a Bachelor’s degree plus five (5) years of manufacturing experience in a regulated industry in lieu of a Bachelor’s degree plus two (2) years of experience.

40 hours/week, 9:00am-5:00pm

Please copy and paste your resume in the email body (do not send attachments, we cannot open them) and email it to candidates at placementservicesusa.com with reference #781076 in the subject line.

Thank you.