Principal Packaging Engineer (Medical Devices)

Location: Fridley, Minnesota, United States; may be based in Rice Creek (West), MN or Plymouth (Berkshire), MN. Flex work model with four days onsite and one day remote weekly; up to 10% travel.

Salary: $124,000–$186,000 annually, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies and sterile medical devices used to improve patient health worldwide.

What you will do

• Lead the design, development, and verification of packaging systems and components for sterile medical devices.
• Develop packaging verification protocols, conduct testing and analysis, and prepare technical reports for product release.
• Evaluate packaging materials and processes and implement improvements in quality, performance, manufacturability, and compliance.
• Support new product commercialization, sustaining engineering, and continuous improvement initiatives with cross-functional teams.
• Manage shelf-life and biocompatibility testing for packaging materials and system changes.
• Support supplier qualification and material approval activities, and mentor Packaging Engineers and Associate Packaging Engineers.

Requirements

• Bachelor's degree with 7+ years of professional experience, or an 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 documents.
• Experience supporting Installation Qualification, Operational Qualification, and Performance Qualification activities.
• Knowledge of FDA, ISO, and packaging industry requirements; packaging experience includes Ethylene Oxide, Steam, and Gamma sterilization methods.
• U.S. work authorization is required; sponsorship is available for Principal-level roles and above.

Nice to have

• Five or more years of medical device packaging or related medical device industry experience.
• Experience with ISO, ASTM, and packaging-related standards.
• Knowledge of project management methodologies and tools.
• Experience identifying, evaluating, and implementing process or material improvements.

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Healthcare Flexible Spending Account, life insurance, and disability coverage.
• Paid time off, paid holidays, sick time where applicable, and employee assistance programs.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance or reimbursement and a global well-being program.