| Looking for MDR Packaging Engineer--Minneapolis, MN at Minneapolis, Minnesota, USA |
| Email: [email protected] |
| From: David Johnson, concord it systems [email protected] Reply to: [email protected] Title: MDR Packaging Engineer Location: Minneapolis, MN Note : This is not a remote position candidate is required to be at site whenever required in addition to mandatory 1 day a week at office. Experience Level Required : Minimum of 3-5 years in medical device or pharmaceutical industry in Packaging Engineering Job Description: The Packaging compliance engineer is part of a dynamic team that provides expertise in the areas of packaging engineering and ensures quality and regulatory compliance. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. Responsibilities may include the following and other duties may be assigned: 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 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. Required Skillset(s) : 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 skill Knowledge of Microsoft Office programs is required. Preferred Skillset(s): CAD/CAPE/TOPS Software knowledge is preferred EUMDR awareness Regulatory awareness ERP and PLM knowledge Thanks & Regards David Johnson Sr.IT Recruiter Desk Number: +1 209 706 0814 Concord Id :[email protected] Keywords: information technology Idaho Minnesota |
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| Tue Feb 28 02:21:00 UTC 2023 |