Associate Manufacturing Engineer (Onsite - Acton)

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
• Assist 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
• Required Skills and Competencies
• Proficient in all 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
• Proficient in Six Sigma/Lean manufacturing concepts
• Comfortable troubleshooting mechanical equipment both Semi and fully automated
• Basic knowledge of common challenges with assembly of molded components, stamped metal, and springs
• Strong command of structured problem-solving tools
• Strong project management skills

Education and Experience

• High School diploma and 10+ years of practical experience in Engineering in a highly regulated manufacturing environment (e.g. Medical, Aerospace, Automotive)
• B.S. in Mechanical/Industrial/Electrical Engineering or equivalent field, and 0-2 years of engineering manufacturing experience.
• Experience in the medical device industry is preferred. High-Volume Manufacturing and/or Automation Experience is a plus.
• Additional Information
• The position is in-person at our Acton location.
• Travel is estimated at 5% but will flex depending on business needs.
• NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite
• 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.
• Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
• We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
• At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
• ( Know Your Rights )

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

Preferred Qualifications

• Experience in the medical device industry is preferred. High-Volume Manufacturing and/or Automation Experience is a plus.