Senior Manufacturing Engineer (Onsite)

Position Overview:   

The Senior Manufacturing Engineer is a critical member of the Global Manufacturing Engineering team supporting the growth and day to day activities of the Operations and Manufacturing Engineering Group.  The person is responsible for KPIs for machine up time and process yield, in addition to managing and executing other manufacturing projects.  Projects may include cost and quality improvements, line qualifications, new product introductions (NPI) and other 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, SOPs, non-conforming material investigations, and tool files. 

Responsibilities:

• Drive product and process improvements in support of Insulet’s Operations (3) main objectives
  • Best Quality
  • Highest Efficiency
  • Lowest cost
• At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing.
• Manage Insulet Automation suppliers and deliver new machines and machine improvements
• 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
• 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
• Identify and carry out manufacturing improvement initiatives
• Support new product introduction initiatives
• Travel to key suppliers to help them carry out critical investigations or improvement projects
• 10% to 25% travel required, mostly international (Canada & China)
• 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

Skills/Competencies:

• Proficient in all Microsoft Office tools
• Excellent Microsoft Excel and Data Analysis Skills – Minitab or JMP preferred
• 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

Behavioral Competencies:

• 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.

Education and Experience:

• B.S. in Mechanical Engineering and 5+ years of medical device experience
• M.S. in Mechanical/Industrial or Engineering Management with 4+ years of experience

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

Additional Information:

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