Staff Manufacturing Engineer

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. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Job Title: Staff Manufacturing Engineer
Department: Manufacturing Engineering

The Staff Manufacturing Engineering is a critical lead member of the Global Manufacturing Engineering team supporting the day to day activities of the Operations and Manufacturing Engineering Group. This leader is the owner of key automation equipment used to produce Insulet products.
This leader is responsible for KPIs for machine up time, process yield and efficiency for his/her group of automation equipment, in addition to managing and executing other manufacturing projects. Projects may include cost and quality improvements, line qualifications, new product introductions (NPI) and others as assigned by manager.
As part of providing support to the operations and Manufacturing 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, SOP, non confirming material investigations and tool files

Responsibilities:
•Responsible for performance and sustainability of automation equipment Drive product and process improvements in support of Insulet's Operations main objectives

1)Best Quality of highest efficiency
2)Highest customer service
3)Lowest cost

• Manage Insulet Automation suppliers and deliver new machines and machine improvements

• At all times maintain 1 cGMP compliant environment and operate within FDA guidelines for Class II Medical Device Manufacturing

• Generate validation/qualification 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

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• 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 confirming 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 production introduction initiatives

• Travel to key suppliers to help them carry out critical investigations or improvement projects

• Carry out duties in a quality system environment

• Posses’ 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

• Perform other duties as required

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
• 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
• Decision Making – has a systematic and methodical approach to making decisions, seeks out and explores relevant information, thinks creatively beyond the immediate problem, assimilates facts quickly, challenges assumptions, and considers business implications of potential solutions.
• Communication Skills – Conveys information effectively, actively listens, resolves conflict constructively.
• Work Organization – Takes a structured, economical approach to resources including time, people, money, and equipment.
• Problem Solving – Uses a systematic, methodical approach to gather facts, define problems, generate and implement solutions.
• Initiative – Makes decisions and takes actions appropriately. Willing to take risks as circumstances require.
• Planning Skills – Sets goals and priorities, thinks ahead, identifies activities and resources needed to achieve goals.
• Perseverance – Achieves objectives by overcoming difficulties through tenacity and resilience.