Supplier Engineer - Packaging (Onsite - Acton, MA)

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 - $105,575.00 This 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 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.