Principal Packaging Engineer
About The Position
The Principal Packaging Engineer is a key member of the Packaging Development function, supporting the design, development, verification, and continuous improvement of packaging systems for sterile medical devices. This role partners with cross-functional teams to commercialize new products, enhance existing packaging solutions, and ensure compliance with regulatory and quality requirements across the product lifecycle. This position may be based in Rice Creek (West), MN or Plymouth (Berkshire), MN and follows a flex work model with four days onsite and one day remote each week. Up to 10% travel may be required in this role. The Principal Packaging Engineer leads packaging development activities for sterile medical devices, supporting both new product development and sustaining engineering initiatives. This role is responsible for designing and verifying packaging systems, driving process and material improvements, and providing technical leadership on packaging-related projects. The individual will work independently, collaborate across functions, and help advance packaging technologies that meet customer, patient, quality, and regulatory requirements.
Requirements
- Bachelor's degree with 7+ years of professional experience, or advanced degree with 5+ years of professional experience.
- Experience developing, validating, or supporting packaging systems for regulated products.
- Experience authoring technical documentation, including protocols, reports, specifications, or validation documentation.
- Experience supporting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
Nice To Haves
- 5+ years of medical device packaging experience or related medical device industry experience.
- Experience working with ISO, ASTM International (ASTM), and packaging-related standards.
- Working knowledge of project management methodologies and tools.
- Experience identifying, evaluating, and implementing process or material improvements.
- Demonstrated analytical, decision-making, written communication, and verbal communication skills.
- Ability to work independently and collaborate effectively with cross-functional stakeholders.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Lead the design, development, and verification of packaging systems and components for sterile medical devices, including products sterilized using Ethylene Oxide, Steam, and Gamma methods.
- Develop and execute packaging verification strategies, including protocol development, testing, analysis, and technical reporting to support product release.
- Evaluate packaging materials and processes and implement improvements that enhance product quality, performance, manufacturability, and compliance.
- Partner with cross-functional teams to support product commercialization, sustaining engineering, and continuous improvement initiatives.
- Manage shelf-life and biocompatibility testing activities for new packaging material combinations and packaging system changes.
- Apply Food and Drug Administration (FDA), International Organization for Standardization (ISO), and packaging industry requirements to ensure compliant package design and validation.
- Support supplier selection, qualification, and material approval activities while serving as a technical liaison with packaging vendors.
- Provide technical guidance and mentorship to Packaging Engineers and Associate Packaging Engineers as needed.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
