Associate Manufacturing Engineer (Onsite - Acton)

Insulet Corporation•Acton, MA

2d•$65,100 - $97,650•Onsite

About The Position

The Associate Manufacturing Engineer, Global Engineering, supports the growth and ongoing operation of Insulet’s manufacturing base at contract manufacturer sites and its U.S. manufacturing facility in Acton, Massachusetts. The role coordinates with equipment suppliers, contract manufacturer counterparts, and Insulet teams to support installation, validation, and performance of manufacturing equipment and processes for the Omnipod product platform. The engineer supports capital equipment projects and is accountable for project budget and timing metrics, as well as equipment uptime, process yield, and efficiency once equipment enters production. The position also conducts structured root-cause investigations and authors or reviews quality-system documentation, including validation records, work instructions, SOPs, nonconforming-material investigations, and tool files. Work is performed in a cGMP-compliant environment under FDA guidelines for Class II medical-device manufacturing. This is an onsite position at Insulet’s Acton location, with travel estimated at 5% and subject to business needs. The listed U.S. annual base salary range is $65,100 to $97,650; the role may also be eligible for incentive compensation.

Requirements

High school diploma and 10 or more years of practical engineering experience in a highly regulated manufacturing environment, such as medical, aerospace, or automotive; alternatively, a B.S. in Mechanical, Industrial, or Electrical Engineering or an equivalent field and 0–2 years of manufacturing engineering experience.
Proficiency with 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.
Proficiency in Six Sigma and Lean manufacturing concepts.
Ability to troubleshoot mechanical equipment, both semi-automated and fully automated.
Basic knowledge of common assembly challenges involving molded components, stamped metal, and springs.
Strong command of structured problem-solving tools.
Strong project-management skills.
Strong mechanical analysis skills.

Nice To Haves

Experience in the medical-device industry.
High-volume manufacturing and/or automation experience.

Responsibilities

Deliver project work for installation of new manufacturing equipment.
Support capital equipment projects and coordinate with suppliers to meet performance, schedule, and budget targets.
Assist with equipment validations and continuous improvement activities at contract manufacturer sites and Insulet’s manufacturing facility.
Drive product and process improvements in support of quality, efficiency, and cost objectives.
Develop and drive continuous improvement efforts.
Maintain a cGMP-compliant environment and operate within FDA guidelines for Class II medical-device manufacturing.
Generate validation and qualification protocols, including OQ, TMV, CSV, and PQ; coordinate protocol execution and prepare final reports.
Author and implement Engineering Change Orders.
Design and coordinate the construction and validation of manufacturing fixtures.
Support project phases from concept, specification, cost justification, and project management through installation, training, qualification, manufacturing implementation, and ongoing support.
Use standardized root-cause investigation templates and problem-solving tools for nonconforming-material investigations.
Implement corrective and preventive actions.
Monitor and report yield and equipment uptime, and lead efforts to keep these KPIs at or above target.
Support new product introduction initiatives.
Travel to key suppliers to assist with critical investigations or improvement projects.
Carry out duties in a quality-system environment.
Analyze products using mechanical engineering methods, including free-body-diagram analysis and fundamental physics.
Interpret selected materials’ mechanical properties and recommend suitable alternatives.
Perform other duties as required.