Associate Manufacturing Engineer (On-site)

Job Title:                             Associate Manufacturing Engineer (On-site)

Department:                     003824 - China Sustaining Engineering

FLSA Status:                      Exempt

Position Overview:

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. 

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

Education and Experience:

Minimum Requirements:

• B.S. in Mechanical Engineering and 2+ years of medical device experience
• M.S. in Mechanical/Industrial or Engineering Management with 1 year of experience

Preferred Skills and Competencies:         

• 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

Physical Requirements (if applicable):          

• Up to 50% travel required, mostly international (China, Canada)
• Able to work both in office and cleanroom production environment

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $65,100.00 - $97,650.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.