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Job Title: Packaging Engineer, Supplier Engineering
FLSA Status: Exempt
Position Overview:
The Supplier Engineer - Packaging Engineer - is a key member of the Supplier Engineering group, which is part of Insulet's Operations organization. Insulet manages a global supply chain and sources precision components and commodities from around the world for use in its devices. The Supplier 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 developing and implementing custom packaging solutions for components and finished medical devices. Candidate is required to have a direct knowledge of applicable packaging standards used in the medical device industry. Candidates should enjoy the factory setting and be comfortable interfacing with and influencing supplier personnel ranging from shop floor operators to leadership.
Responsibilities:

• Lead, manage and implement packaging projects from kick-off through production ramp.
• Design, develop, and qualify medical device packaging systems, including sterile barrier systems (e.g., trays, pouches, blisters, cartons)
• Perform and document package validation activities per ISO 11607, including seal integrity, transportation, and shelf-life testing
• Generate validation/qualification protocols and coordinate their execution and final reporting.
• Identify, justify, and implement process improvement opportunities associated with form, fit and function of the device and component packaging.
• Participate in product design reviews with emphasis on design for manufacture to optimize form, fit or function of the device / component packaging.
• Troubleshoot packaging-related issues on the manufacturing floor and with contract manufacturers
• Identify and define the global packaging requirements for both device and component packaging for the organization.
• Evaluate and qualify packaging materials and suppliers
• Ensure packaging designs comply with applicable regulatory and quality system requirements (FDA, ISO, internal SOPs)
• Collaborate cross-functionally with R&D, Quality, Manufacturing, Supply Chain, and external suppliers
• Establish standards and guidelines for supplier selection on new and existing packaging suppliers. Confirm through audits
• All other duties as assigned

Education and Experience:
Minimum Requirements:
• BS Engineering Degree (Mechanical, Materials or Packaging background)
• 2+ years in a regulated industry (relevant co-op experience will be considered)
Preferred Skills and Competencies:
• Ability to manage Supply Chain projects concept to production, including the authoring and oversight of IQ/OQ/PQ protocols for packaging qualifications.
• Strong written and verbal communication skills
• Knowledge of packaging standards and requirements for component level and finished medical device requirements.
• 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 25% of the time
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 $70,400.00 - $105,575.00This 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 programsApplication 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.
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