Senior Manufacturing Engineer; Onsite - Acton, MA

Senior Manufacturing Engineer

This Senior Manufacturing Engineer role is responsible for supporting both new manufacturing line/equipment implementation and continuous improvement of existing production processes for Insulet's Omnipod products. The position focuses on driving manufacturing excellence through improved quality, efficiency, and cost reduction while leading equipment validation, troubleshooting, root cause investigations, and process optimization activities. Working closely with suppliers, contract manufacturers, and cross-functional teams, the engineer will manage projects from concept through production, monitor key performance metrics such as yield and equipment uptime, and ensure compliance with medical device quality and regulatory requirements.

The ideal candidate has a strong engineering background, experience in medical device manufacturing, expertise in automation and process improvement, and a passion for solving complex manufacturing challenges in a highly regulated environment.

Position Overview:

The candidate will work both on the addition of new manufacturing lines and equipment, as well as continuous improvement efforts for existing manufacturing processes/equipment. 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.

The candidate will be responsible for KPIs for project budget and timing, as well as machine up-time, process yield and efficiency once equipment is in production. As part of providing support to the Global Manufacturing Engineering Group, the candidate will also carry out root cause investigations using structured problem-solving tools and will author and review quality system documentation such as validations, work instructions, SOPs, non-conforming material investigations, and tool files.

Responsibilities:

• Drive product and process improvements in support of Insulet's Operations (3) main objectives:
  Best Quality, Highest Efficiency, Lowest cost
• 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
• Up to 5% travel required, ability to travel internationally
• Performs other duties as required

Skills/

Competencies:

• Proficient in all Microsoft Office tools
• Excellent Microsoft Excel and Data Analysis Skills
• Working knowledge of Minitab and/or JMP statistical analysis software
• Working Knowledge of Solidworks and print reading
• Proficient in Six Sigma/Lean manufacturing concepts
• Comfortable troubleshooting mechanical equipment both Semi and fully automated
• Basic knowledge of common challenges with assembly of molded components, stamped metal, and…