Packaging and Labeling Engineer (Medical Devices)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Packaging and Labeling Engineer (Medical Devices): Developing and implementing packaging and labeling solutions for commercial medical device products with an accent on regulatory compliance, design controls, validation, and quality systems. Focus on solving packaging and labeling issues, managing design changes, and delivering compliant solutions within aggressive project timelines.
Location: Remote, with onsite presence required during the initial training period.
Salary: $120,000–$155,000 annually.
Company
provides consulting and technical services for the development, manufacturing, and distribution of healthcare and life sciences products.
What you will do
- Develop, review, and implement packaging and labeling designs for medical device products.
- Ensure compliance with FDA regulations, ISO standards, design controls, and internal quality systems.
- Review packaging specifications, labeling content, artwork, and related documentation.
- Support packaging validation, risk assessments, change management, and design control activities.
- Collaborate with Quality, Regulatory Affairs, Manufacturing, Supply Chain, and Product Development.
- Troubleshoot technical issues and drive project deliverables through implementation.
Requirements
- Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
- 5+ years of packaging and/or labeling engineering experience in the medical device industry.
- Strong knowledge of FDA medical device regulations, design controls, quality systems, and applicable ISO standards.
- Experience with risk management, change control, verification, validation, and packaging specifications.
- Experience supporting commercial product launches, remediation activities, or packaging and labeling design changes.
- Ability to work independently, communicate effectively, and deliver results with minimal oversight.
Culture & Benefits
- Three- to four-month contracted remote assignment.
- Onsite initial training is required.
- W2 temporary roles include medical and sick time benefits.
- Professional development and coaching opportunities are provided.
- No visa sponsorship is available.
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