Junior software engineer/Java developer remote SynergisticIT
Hartford, CT19 days agoRemote
- $82,000–$136,000 Per Year
- Full-time
Katalyst Healthcares & Life Sciences
- North Haven, CT
- 30+ days ago
Highlights
Packaging Engineer provides technical leadership for packaging development and validation, ensuring products meet quality and regulatory requirements while driving process improvements and supporting cross-functional initiatives. 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.
Numbers & Facts
| Location | North Haven, CT |
Description
Summary:
The Sr. Packaging Engineer provides technical leadership for packaging development and validation, ensuring products meet quality and regulatory requirements while driving process improvements and supporting cross-functional initiatives.
Roles & Responsibilities:
The Sr. Packaging Engineer provides technical leadership for packaging development and validation, ensuring products meet quality and regulatory requirements while driving process improvements and supporting cross-functional initiatives.
Roles & Responsibilities:
- 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.
- Bachelor's degree in engineering
- 5+ years of medical device or pharma packaging experience
- Validation of Packaging Systems
- Gap Analysis
- ISO11607
- Ability to conduct Packaging systems Gap Analysis according to ISO11607 Part 1
- Experience leading project meetings
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