MDR - Packaging Engineer
Integrated Resources, Inc Boulder, CO
- Expired: over a month ago. Applications are no longer accepted.
Duration: 12 months
Location: Boulder, CO
Candidate must be local to Boulder, CO.
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.
- Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.
- Minimum of 3-5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.
- Requires practical knowledge and demonstrated competence within packaging engineering typically obtained through advanced education combined with experience.
- Knowledge and general understanding of ISO 11607 part 1 and 2, ASTM and ISTA package test methods is required.
- Established and productive individual contributor with strong team and interpersonal skills.
- Knowledge of Microsoft Office programs is required.
- CAD/CAPE/TOPS Software knowledge is preferred.