Packaging Engineer

Location: Maple Grove, MN
Salary: TBD
Description:
We are seeking an experienced Senior Packaging Engineer with a strong background in medical device packaging and sterile packaging to join our dynamic team. The ideal candidate will have a minimum of 5 years of experience in the medical device industry and a proven track record of success in developing packaging solutions that meet regulatory requirements and ensure product integrity.

Responsibilities include:

• Packaging Design and Development: Lead the design and development of packaging solutions for medical devices, ensuring compliance with industry standards and regulations (e.g., ISO 11607, FDA guidelines).
• Sterile Packaging Expertise: Develop and implement sterile packaging processes and protocols to maintain product sterility throughout the distribution chain.
• Material Selection and Testing: Evaluate and select appropriate packaging materials based on product requirements and compatibility, conducting material testing and validation as needed.
• Packaging Validation: Plan and execute packaging validation activities, including accelerated aging studies, package integrity testing, and transportation testing.
• Risk Management: Conduct risk assessments related to packaging design and processes, identifying potential hazards and implementing mitigation strategies.
• Cross-functional Collaboration: Collaborate with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and Operations, to ensure alignment and integration of packaging requirements throughout the product lifecycle.
• Regulatory Compliance: Stay abreast of regulatory developments and industry trends related to medical device packaging, ensuring compliance with applicable regulations and standards.
• Continuous Improvement: Drive continuous improvement initiatives related to packaging design, processes, and cost optimization, leveraging best practices and innovative technologies.

Qualifications:

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, or related field; advanced degree preferred.
• Minimum of 5 years of experience in medical device packaging, preferably in a regulated environment.
• Strong knowledge of packaging materials, sterilization methods, and packaging validation principles.
• Proficiency in relevant software tools (e.g., CAD software, statistical analysis tools).
• Experience with regulatory requirements for medical device packaging (e.g., FDA, ISO 13485).
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills, with the ability to collaborate effectively across functional teams.
• Project management experience, with the ability to prioritize and manage multiple projects simultaneously.

Contact:

This job and many more are available through The Judge Group. Please apply with us today!