Senior Packaging Engineer for Medical Device Development

3 weeks ago

Irvine, California, United States Pharmavise Corporation Full time
About the Role

We are seeking a highly skilled Senior Packaging Engineer to join our team in Irvine, CA. This is a hybrid contract position with a duration of 12 months.

Job Summary

The successful candidate will be responsible for the development and analysis of packaging solutions for medical devices. This includes collaborating with cross-functional teams to ensure project success and maintaining high-quality standards.

Key Responsibilities
  • Participate in due diligence and integration activities as required.
  • Contribute to project teams through packaging/product design and development, testing, specification preparation, process capability studies, report writing, and documentation.
  • Analyze proposed packaging design changes and provide justification and/or data collection to verify performance requirements.
  • Work independently to plan and schedule activities necessary to meet project timelines.
  • Collaborate with project management, quality, R&D, manufacturing, regulatory, operations, and marketing teams to ensure project success.
  • Design, qualify, and procure packaging components from external suppliers.
  • Perform packaging testing and/or bench study experiments for commercial design improvements.
  • Participate in resource planning and the development and implementation of new team members for supporting due diligence and integration activities.
  • Generate packaging-related documentation, including test protocols and reports.
  • Perform root cause analysis related to design, material, or process failures.
  • Summarize, analyze, and draw conclusions from test results.
  • Design, procure, and fabricate tooling and fixtures.
  • Train technicians or operators on new processes or test procedures.
  • Identify areas for continuous improvement and stay up-to-date with new technologies and advances in the packaging industry.
Requirements
  • B.S. degree in Packaging (or equivalent experience).
  • A minimum of 3 years of R&D Packaging Engineering experience, preferably in the medical device industry.
  • Knowledge of ISO 11607 Part I & II, ASTM, and ISTA Standards.
  • Quality-driven individual with a strong work ethic, highly motivated, tenacious, and meticulous in execution.
  • Demonstrated problem-solving capability.
  • Strong communication skills (oral, written, and virtual).
  • Ability to manage simultaneous projects and timelines effectively.
  • Understanding of quality system controls (user needs, design inputs/outputs, design verification/validation, etc.).
  • Familiarity with paperboard, flexible packaging films, Tyvek, thermoformed trays, injection-molded parts, MEE/crates, returnable or reusable, temperature-controlled, and packaging equipment.
  • Packaging process and equipment qualification experience.
What We Offer

We offer a competitive salary of $85,000 - $110,000 per year, depending on experience, and a comprehensive benefits package. Our company values excellence through quality and provides opportunities for professional growth and development.

About Pharmavise Corporation

Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device, and Biotechnology clients. We prioritize teamwork, innovation, and customer satisfaction. As an equal opportunity employer, we welcome applications from diverse candidates who share our commitment to quality and excellence.

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