Title : MDR Packaging Engineer
Location : Boulder, CO
Job Description :
Experience Level Required :
Minimum of 3-5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.
The Packaging compliance engineer is part of a dynamic team that provides expertise in the areas of packaging engineering and ensures quality and regulatory compliance. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. Responsibilities may include the following and other duties may be assigned:
• Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2.
• Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation.
• Leads successful validation of packaging systems for medical devices
• Identify and develop innovative packaging processes and designs as part of a cross functional team. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required.
• Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.
• Lead project meetings and provide updates to management.
• Assist in labeling development process.
• May perform and evaluate testing in a laboratory environment as per industry standards.
Must to have:
EU MDR Tech documentation Summary
Understanding of ISO 11607-1 and ISO11607-2
Understanding of ASTM and ISTA package test method
CAD/CAPE/TOPS Software knowledge
RAC Certification: Medical Devices
Good To Have
US and EU Submission
Worldwide regulatory agencies/authorities
CE Technical File / EU Technical File / Design Dossier
Support EU MDR Transition activities
EU MDR Gap Analysis
Collateral/Product specific IEC Standards Knowledge