Manufacturing Engineer Jobs

MANUFACTURING ENGINEER
LOCATION
Acton, MA
Company
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform.
Job Summary
The Manufacturing Engineer, Global Engineering, will be a key team member in the growth and ongoing support of Insulet’s manufacturing. This 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.
SALARY
Starting at $80K - Commensurate with experience
Responsibilities

• Up to 5% travel required, ability to travel internationally
• Develop and drive Continuous improvement efforts.
• Support new product introduction initiatives
• Author and implement Engineering Change Orders
• At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing.
• Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above target
• Implement corrective and preventive actions
• Generate validation/qualification (IQ, OQ, TMV, CSV, PQ) protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports
• Use standardized root cause investigation templates and problem solving tools to carry out non-conforming material investigations
• Travel to key suppliers to help them carry out critical investigations or improvement projects
• Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support.
• Carry out duties in a quality system environment
• Support equipment validation and continuous improvement activities at Insulet manufacturing facilities
• Project deliverables for installation of new manufacturing equipment and manufacturing equipment upgrades
• Analyze a product using mechanical engineering methods such as FBD analysis and fundamental physics.
• Possesses strong mechanical analysis skills
• Drive product and process improvements in support of Insulet’s Operations

Qualifications

• Experience in a medical device manufacturing company or with automated equipment a plus
• 2+ years of manufacturing engineering experience
• Basic knowledge of Six Sigma/Lean manufacturing concepts
• Basic knowledge of Minitab and/or JMP statistical analysis software, Solidworks and Excel
• BS. in Mechanical/Industrial/Electrical Engineering
• Experience troubleshooting manufacturing equipment

Company is an Equal Opportunity Employer and is committed to diversity in our workforce. EOE/M/F/D/V