Supplier Project 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.

The Supplier Project Engineer is a key member of the Supplier Engineering group, which is part of Insulet’s R&D organization. Insulet manages a global supply chain and sources precision components and commodities from around the world for use in its devices. The Supplier Project Engineer works closely with peers and leaders in Quality, Sourcing and Manufacturing to implement new capital tooling and equipment at suppliers, carry out new product introductions, execute improvement projects, resolve business-critical technical issues, and investigate and lead corrective actions in response to quality issues across the supply base.
The ideal candidate has experience working with suppliers of custom precision components for use in medical devices and should have either strong mechanical/automation experience or strong process/data analysis experience, or both.

Responsibilities:
• Lead, manage and implement supplier capital qualifications from kick-off to implementation into production
• Generate validation/qualification protocols and coordinate their execution and final reporting
• Identify, justify, and implement process improvement opportunities within regulated tier 1 component suppliers
• Travel to suppliers to lead capital qualification projects, as well as to root cause and implement corrective actions in response to quality issues
• Participate on teams responsible for the procurement and installation of manufacturing equipment at global suppliers
• Participate in product design reviews with emphasis on design for manufacture
• All other duties as assigned

Minimum Requirements:
• BS Engineering Degree (Mechanical, Manufacturing/Industrial, Bio-medical, Chemical)
• 4 years in a regulated industry

Preferred Skills and Competencies:
• Ability to manage Supply Chain projects concept to production, including the authoring and oversight of IQ/OQ/PQ protocols for component manufacturing processes and secondary operations.
• Strong written and verbal communication skills

Familiarity with the injection molding and/or metal forming.

• Familiarity with Solidworks / Pro-E and one of SAS, JMP, or Minitab
• Working knowledge of MS Office, including Office Project software.
• Six Sigma Process Improvement Experience/Certification desirable.
• Familiarity with cGMP practices desired
• Outstanding team player who seeks and values diverse input to hone ideas, but who has the experience to develop strong starting proposals
• Highly-motivated, self-starter
• Appreciates the value of timelines and enjoys working in the focused environment that they create

Physical Requirements (if applicable):
• Willingness to travel approximately 10% to 25% of the time