12+ month contract
M-F / Onsite
Responsible for medical device packaging design, qualification, and EU MDR packaging remediation to ensure compliance with industry standards and regulations.
Requirements :
- BS in Packaging, Mechanical Engineering, or related field
- 3–5+ years of experience in medical device or pharmaceutical packaging engineering
- Knowledge of medical device package design and qualification
- Understanding of ISO 11607-1 and -2 standards
- Experience in regulated industries such as medical devices or pharmaceuticals
- Background in EU MDR packaging remediation projects
Preferred Skills :
Familiarity with ASTM and ISTA package test methodsExperience supporting regulatory audits and drafting technical responsesKnowledge of sterile barrier systems and non-sterile medical device packagingResponsibilities :
Evaluate current medical device packaging designs and perform gap analysis against ISO 11607 standardsDevelop and execute EU MDR packaging remediation plans, protocols, and reportsLead validation of medical device packaging systemsDefine packaging specifications based on product requirements, cost, regulations, and protection needsCollaborate with cross-functional teams to develop innovative packaging processes and designsUpdate specifications, technical documentation, and labeling in compliance with regulatory requirementsSupport regulatory audits with technical expertise and compliance documentationLead project meetings and present updates to managementPerform and evaluate laboratory testing of packaging systems per industry standardsEqual Opportunity Employer / Veterans / Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer : These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
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The Company will consider qualified applicants with arrest and conviction records.