Associate Manufacturing Engineer (On-site)

Insulet Corporation•Acton, MA

2d•$65,100 - $97,650•Onsite

About The Position

The Associate Manufacturing Engineer, Global Engineering, will be a key team member in the growth and ongoing support of Insulet’s manufacturing base across the world, at Contract Manufacturer (CM) sites and at Insulet’s US Manufacturing facility in Acton, MA. The candidate will be based out of Insulet HQ in Acton, MA, but will be expected to travel frequently to manufacturing sites as required to complete project deliverables. This candidate will be 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 use his/her 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 manufacturing equipment and processes. The person 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 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.

Requirements

B.S. in Mechanical Engineering and 2+ years of medical device experience

Nice To Haves

M.S. in Mechanical/Industrial or Engineering Management with 1 year of experience
Proficient in all Microsoft Office tools
Excellent Microsoft Excel and Data Analysis Skills – Minitab of JMP
Proficient in Solidworks and drafting skills
Understanding of Six Sigma/Lean manufacturing concepts
Comfortable troubleshooting mechanical equipment both Semi and fully automated
Basic knowledge of common challenges with assembly of molded components required
Strong command of structured problem solving tools
Excellent project management skills
Systematic decision making, organizational, and personal planning skills
Strong written and verbal communication skills

Responsibilities

Project deliverables for installation of new manufacturing equipment
Support of capital equipment projects including coordination with suppliers to ensure performance, timing and budget targets are met
Assistance with equipment validations and continuous improvement activities at CM and at Insulet manufacturing facility
Drive product and process improvements in support of Insulet’s Operations (3) main objectives Best Quality Highest Efficiency Lowest cost
Develop and drive Continuous improvement efforts.
At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing.
Generate validation/qualification (OQ, TMV, CSV, PQ) protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports
Author and implement Engineering Change Orders
Design and coordinate the construction and validation of manufacturing fixtures
Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support.
Use standardized root cause investigation templates and problem solving tools to carry out non-conforming material investigations
Implement corrective and preventive actions
Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above target
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
Possesses strong mechanical analysis skills
Analyze a product using mechanical engineering methods such as FBD analysis and fundamental physics.
Interpret the mechanical properties of the selected material for the product design and make recommendations for suitable alternatives.
Performs other duties as required