About the Company
Medtronic is a global leader in medical technology, alleviating pain, restoring health, and extending life for millions of people worldwide. We are committed to innovation and making healthcare accessible. Join our team and be part of a company that is transforming healthcare.
Job Description
We are seeking a highly motivated and experienced Packaging Engineer to join our innovative team in Irvine, CA. This role is critical to the design, development, and validation of packaging solutions for our cutting-edge medical devices, ensuring product integrity, regulatory compliance, and patient safety. The successful candidate will work collaboratively with cross-functional teams including R&D, manufacturing, quality, and regulatory affairs to bring life-changing products to market. Relocation assistance will be provided for qualified candidates.
Key Responsibilities
- Design, develop, and test packaging systems for medical devices, including sterile barrier systems and distribution packaging.
- Generate and execute packaging validation protocols (IQ, OQ, PQ) and reports.
- Conduct material selection, testing, and qualification for new and existing packaging components.
- Collaborate with R&D and manufacturing to ensure packaging designs are optimized for manufacturability and cost-effectiveness.
- Provide technical support for packaging related issues, including root cause analysis and corrective actions.
- Ensure all packaging designs and processes comply with relevant industry standards (e.g., ISO 11607) and regulatory requirements.
- Manage multiple packaging projects from concept through commercialization.
- Participate in risk assessments and FMEA activities related to packaging.
- Maintain accurate documentation and specifications for all packaging designs.
Required Skills
- Bachelor's degree in Packaging Engineering, Mechanical Engineering, or a related field.
- Minimum of 3 years of experience in packaging engineering within the medical device, pharmaceutical, or other regulated industry.
- Demonstrated experience with sterile barrier packaging design and validation (ISO 11607).
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) for packaging design.
- Strong understanding of packaging materials, testing methods, and equipment.
- Knowledge of FDA, CE, and other international regulatory requirements for medical device packaging.
- Excellent problem-solving, analytical, and communication skills.
- Ability to manage projects and work effectively in a team environment.
Preferred Qualifications
- Master's degree in Packaging Engineering or a related field.
- Certified Packaging Professional (CPP) certification.
- Experience with packaging automation and lean manufacturing principles.
- Familiarity with Design of Experiments (DOE) and statistical analysis tools.
- Previous experience working with suppliers and external vendors for packaging components.
Perks & Benefits
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement plan with company match.
- Paid time off, including vacation, sick leave, and holidays.
- Life and disability insurance.
- Relocation assistance program.
- Tuition reimbursement and professional development opportunities.
- Employee assistance program.
- On-site fitness centers and wellness programs (at select locations).
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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