SR.
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 Sr. 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 $120K - Commensurate with experience
RESPONSIBILITIES
Drive product and process improvements in support of Insulet's Operations 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 QUALIFICATIONS
5+ years of manufacturing engineering within a medical device manufacturing company Medical device validation experience Experience troubleshooting manufacturing equipment Experience with automated equipment a plus Experience with Minitab and/or JMP statistical analysis software, CAD or Solidworks and Excel Knowledge of Six Sigma/Lean manufacturing concepts BS in Mechanical/Industrial/Electrical Engineering Company is an Equal Opportunity Employer and is committed to diversity in our workforce.
EOE/M/F/D/V
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