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Packaging Engineer
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Senior Design Packaging Engineer - Grand Rapids, MI
Overview: A leading medical device company is seeking a Sr. Design Packaging Engineer to join their Packaging and Labeling team for a yearlong contract in Grand Rapids, MI. This individual will play a pivotal role in various sustaining packaging engineering projects, focusing on quality, cost savings, and service.
Key Responsibilities:
- Lead and support packaging engineering projects for both sterile barrier systems and non-sterile medical device packaging.
- Develop and execute packaging remediation and qualification plans.
- Define qualification plans, author and execute Design Verification (DV), aging protocols, testing, and closing reports.
- Utilize knowledge of quality and regulatory compliance to support regulatory body audits, Corrective and Preventive Actions (CAPA), and Nonconformance Material Reports (NCMR).
- Provide innovative solutions to ensure compliance with the latest industry practices.
- Conduct gap analysis on existing packaging designs against current industry standards such as ISO 11607 Part 1 and 2.
- Determine packaging specifications based on product nature, cost constraints, legal requirements, and required device protection.
- Update packaging material specifications and technical documentation.
Required Skills & Experience:
- Minimum of 3-5 years in packaging engineering within the medical device or pharmaceutical industry.
- Practical knowledge and demonstrated competence in packaging engineering, typically obtained through advanced education and experience.
- Understanding of ISO 11607 Part 1 and 2.
- Bachelor’s degree in Packaging Science, Mechanical Engineering, or a related discipline.
Preferred Skills & Experience:
- Experience with Form-Fill-Seal (FFS) equipment.
- Experience with CAPA and NCMR processes.
- Advanced education or degree in a related field.
Additional Information:
- The ideal candidate will have a strong background in the medical device or pharmaceutical industry.
- Must be comfortable working onsite in Grand Rapids, MI, three days a week.