What are the responsibilities and job description for the Packaging Engineer position at Premier Life Sciences LLC?
Role: Packaging Engineer
Location: Warsaw, Indiana & San Jose, CA
Duration: 12 Months - Onsite
**Only W2/1099 - No C2C**
We are seeking a Packaging Engineer to join our client's team, focusing on innovative and compliant packaging solutions for medical devices. This role will involve designing, validating, and implementing packaging systems that meet regulatory requirements and ensure the safety and efficacy of medical devices during distribution and storage.
Key Responsibilities:
- Design and develop packaging solutions for medical devices, considering material compatibility, sterilization methods, and user requirements.
- Conduct packaging validation studies, including transit testing, environmental conditioning, and sterile barrier integrity testing, to ensure compliance with ISO 11607 and other applicable standards.
- Collaborate with cross-functional teams, including product development, quality assurance, and regulatory affairs, to support new product introductions and packaging improvements.
- Prepare and maintain packaging specifications, drawings, and standard operating procedures (SOPs).
- Lead or support packaging-related risk assessments and failure investigations.
- Stay updated on industry trends, materials, and technologies to enhance packaging strategies.
Qualifications:
- Bachelor's degree in Packaging Engineering, Mechanical Engineering, or a related field.
- 3 years of experience in medical device packaging, with knowledge of sterilization processes (e.g., EO, radiation, steam).
- Familiarity with relevant standards and regulations, including ISO 11607, FDA 21 CFR Part 820, and EU MDR.
- Proficiency in CAD software for packaging design is a plus.
- Strong problem-solving skills and attention to detail, with the ability to work effectively in a team environment.
