Packaging and Labeling Engineer

About the role

We are seeking an experienced Packaging & Labeling Engineer to support the design, development, and implementation of packaging and labeling solutions for medical device products. This role focuses on ensuring compliance with regulatory requirements, quality standards, and business objectives.

Responsibilities

• Develop, review, and support packaging and labeling designs for medical device products.
• Ensure packaging and labeling activities comply with applicable FDA regulations, ISO standards, and internal quality system requirements.
• Collaborate with cross-functional teams including Quality, Regulatory Affairs, Manufacturing, Supply Chain, and Product Development.
• Support design control activities, documentation, and change management processes related to packaging and labeling.
• Review packaging specifications, labeling content, artwork, and associated documentation for accuracy and compliance.
• Participate in risk assessments and identify opportunities to improve packaging performance, product protection, and labeling effectiveness.
• Absorb and implement packaging validation activities, including test protocol development, execution, and reporting.
• Support implementation of packaging and labeling changes while maintaining compliance with quality and regulatory requirements.
• Troubleshoot packaging and labeling issues and provide timely technical solutions.
• Drive project deliverables and meet aggressive timelines while maintaining quality and compliance standards.

Requirements

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• 5+ years of experience in packaging and/or labeling engineering within the medical device industry.
• Strong knowledge of FDA medical device regulations, design controls, and quality system requirements.
• Familiarity with applicable ISO standards and related medical device regulations.
• Experience developing and implementing packaging and labeling solutions for commercial medical device products.
• Working knowledge of risk management, change control, verification, and validation processes.
• Experience reviewing packaging specifications, labeling content, artwork, and associated documentation for regulatory compliance.
• Ability to work independently and drive deliverables with minimal oversight in a fast-paced environment.
• Strong communication and collaboration skills with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, and Product Development.
• Packaging validation and labeling compliance experience.
• Experience supporting product launches, remediation activities, or packaging/labeling design changes.

Benefits

W2 Temp roles include our Medical and Sick Time benefits. Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $120,000 - $155,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.