Entegee
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 35+ 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 methods Experience supporting regulatory audits and drafting technical responses Knowledge of sterile barrier systems and non-sterile medical device packaging
Responsibilities: Evaluate current medical device packaging designs and perform gap analysis against ISO 11607 standards Develop and execute EU MDR packaging remediation plans, protocols, and reports Lead validation of medical device packaging systems Define packaging specifications based on product requirements, cost, regulations, and protection needs Collaborate with cross-functional teams to develop innovative packaging processes and designs Update specifications, technical documentation, and labeling in compliance with regulatory requirements Support regulatory audits with technical expertise and compliance documentation Lead project meetings and present updates to management Perform and evaluate laboratory testing of packaging systems per industry standards
Equal 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 To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit
https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records.
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 35+ 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 methods Experience supporting regulatory audits and drafting technical responses Knowledge of sterile barrier systems and non-sterile medical device packaging
Responsibilities: Evaluate current medical device packaging designs and perform gap analysis against ISO 11607 standards Develop and execute EU MDR packaging remediation plans, protocols, and reports Lead validation of medical device packaging systems Define packaging specifications based on product requirements, cost, regulations, and protection needs Collaborate with cross-functional teams to develop innovative packaging processes and designs Update specifications, technical documentation, and labeling in compliance with regulatory requirements Support regulatory audits with technical expertise and compliance documentation Lead project meetings and present updates to management Perform and evaluate laboratory testing of packaging systems per industry standards
Equal 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 To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit
https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records.