Packaging Leadership Role
1 week ago
The ideal candidate will have experience in sterile packaging system development and validation, with knowledge of ISO 11607, EU MDR, UDI, ASTM D10 and F02, IEC 62366, and FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices.
This senior role involves leading cross-functional projects for new product development and commercialization, and changes to existing products. The individual will be responsible for recommending new packaging materials, equipment, and suppliers, as well as developing and validating sterile packaging and labelling systems and equipment.
Key Responsibilities:- Lead cross-functional projects for new product development and commercialization, and changes to existing products.
- Recommend new packaging materials, equipment, and suppliers.
- Develop and validate sterile packaging and labelling systems and equipment.
- Ensure compliance with and monitor changes to packaging regulations.
- Write and coordinate technical documentation, including design assurance documents, protocols, reports, procedures, specifications, work instructions, and original data.
- Develop and validate test methods.
- Source and validate packaging test equipment.
- Identify and support cost savings opportunities.
- Represent the company at industry events (conferences, seminars, etc.).
- Educate the organization on packaging best practices.
- Strong background in medical device packaging engineering.
- Experience in cross-functional project leadership.
- Knowledge of regulatory requirements such as ISO 11607, EU MDR, UDI, ASTM D10 and F02, IEC 62366, and FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices.
- Excellent communication and coordination skills.
- Able to develop and implement effective solutions.
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