Humacao, Puerto Rico (Hybrid Remote - 4 days of in-office )
$80,000 to $85,000 + Full benefits package provided
We are seeking a highly experienced and dedicated Senior Packaging Engineer to join our team in Humacao, Puerto Rico. This crucial, onsite role will lead the development and implementation of robust, compliant, and cost-effective packaging solutions for medical devices in a fast-paced manufacturing environment. The successful candidate will be a maker of possible , ensuring packaging integrity throughout the entire product lifecycle and supporting continuous operational excellence.
Design and Development: Lead the design, development, and validation of primary and secondary packaging systems for medical devices, ensuring compatibility with materials, sterilization methods, and manufacturing processes.
Technical Support & Troubleshooting: Provide expert on-site technical support for packaging processes, swiftly troubleshooting issues, performing root cause analysis, and implementing effective corrective and preventative actions.
Testing and Documentation: Conduct and meticulously document all required packaging testing, including but not limited to seal strength, integrity, transit simulation, and bioburden, adhering to internal protocols and industry standards.
Compliance and Validation: Maintain up-to-date knowledge of and ensure compliance with all relevant packaging regulations and standards (e.g., ISO 11607). Participate actively in audits, risk assessments, and rigorous validation activities.
Project Leadership: Support new product introductions and major packaging changes, leading efforts through the design control and change management processes.
Continuous Improvement: Drive operational efficiency and cost reduction initiatives related to packaging materials, equipment, and processes.
Education: Bachelor’s degree in Packaging Engineering, Mechanical Engineering, or a related technical field.
Experience: Minimum of 5 years of experience in medical device packaging , with a strong preference for experience gained within a manufacturing environment.
Technical Knowledge: Strong understanding of packaging materials, sterilization techniques, and regulatory requirements (e.g., FDA, ISO).
Environment: Experience working in a GMP-compliant environment .
Skills: Excellent problem-solving, analytical, communication, and organizational skills.
Software: Proficiency in Microsoft Office applications.
Specific experience with different types of packaging sealers and various package formats (e.g., pouches, trays, blister packs).
Involvement in sealer process validation activities.
Demonstrated knowledge and experience in package performance and shelf-life qualifications .
Prior experience working directly with product development or product engineering teams .
Familiarity with CAD or packaging design software is a plus.
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