Location:
Irvine, CA
Schedule:
Standard Office Hours - onsite 4 days per week
Duration:
12-Month Contract
Pay rate:$45-$50 an hour
Job Summary:
Seeking a Packaging Engineer to develop innovative packaging solutions and manage projects within an R&D packaging development team. This role involves designing, validating, and implementing packaging for medical devices across all stages of product development.
Key Responsibilities:
- Design packaging concepts for new and existing products, including clinical trials and global market releases.
- Develop and execute packaging validation protocols (IQ, OQ, PQ), shelf-life testing, and process validation.
- Collaborate with cross-functional teams and suppliers to drive packaging technologies and improvements.
- Validate packaging equipment and manufacturing processes.
- Provide guidance and coaching to junior engineers.
Required Skills:
- Experience in medical device packaging design and development.
- Knowledge of packaging verification and validation.
- Familiarity with regulatory standards (ISO-11607, ASTM D4169) and sterilization methods.
- Experience with materials such as Tyvek, PETG, Polycarbonate, and thermoforming or injection molding processes.
- Proficiency in SolidWorks and Minitab.
Preferred Skills:
- IQ, OQ, PQ experience.
- Strong technical writing and documentation skills.
- Ability to manage vendors and stakeholders in a fast-paced environment.
Requirements:
- Bachelor’s degree in engineering (Master’s preferred).
- 4+ years of experience in a regulated industry.
- No visa sponsorship available.
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