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:
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.
