Sr Packaging Engineer

Top 3 technical skills that are required for the role:Leads successful validations of packaging systems for medical devicesAble to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2Lead project meetings and provide updates to managementEducation Required: Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar disciplineYears’ Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in PackagingWill the contractor be working 40 hours a week? If not, weekly estimate? 40 hoursDoes this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hybrid, onsite 4 days per week (North Haven CT or Lafayette CO) Please list which location at the top of the resume when submitting candidatesWhat is your timeline for scheduling interviews? ASAPWhat product line will this person support? Various within Surgical OUResponsibilitiesThe packaging engineer is part of a dynamic team that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads 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 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 devicesIdentify 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 RequirementsBachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.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 required.Established and productive individual contributor with strong team and interpersonal skills.Knowledge of Microsoft Office programs is required.CAD/CAPE/TOPS Software knowledge is preferred.