Job Description
Pay 45-55/h
Top 3 technical skills that are required for the role:
1. Knowlege and working experience in Medical Device Package Design and qualification 2. Understanding of Packaging Engineering Industry Standards and regulations (i.e. ISO 11607-1,-2)3. Experience in regulated industry, medical devices or pharmaceutical Education Required: Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline Years’ Experience Required: Minimum of 3-5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite 4 days per week What is your timeline for scheduling interviews? ASAP What product line will this person support? Surgical Operating Unit The packaging engineer is part of a dynamic team that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads EU MDR packaging remediation projects and collaborates with stakeholders to achieve desired results. Responsibilities include the following:
· 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 EU MDR 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.
· May perform and evaluate testing in a laboratory environment as per industry standards.
Minimum Requirements
· Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.
· Minimum of 1-3 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.
· Established and productive individual contributor with strong team and interpersonal skills.
· Requires practical knowledge and demonstrated competence within packaging engineering typically obtained through advanced education combined with experience.
· Knowledge and general understanding of ISO 11607 part 1 and 2, ASTM and ISTA package test methods is preferred.
· Knowledge of Microsoft Office programs is required.
CAD/CAPE/TOPS Software knowledge is preferred.
Job Tags
Contract work, For contractors, Work experience placement, Work at office, Immediate start, Remote work,