Description:
Support EU MDR execution and implementation on SNV products. Design and develop best in class packaging and labeling solutions from early concept through commercialization for sterile and non-sterile medical devices. Drive continuous improvement and assessment of current procedures and Voice of the Customer input and identify best practices. Develop packaging and labeling components that improve the customer experience, working with a drafter to develop 3D models and Artwork. Demonstrate development life cycle knowledge through delivery of high-quality deliverables. Work cooperatively with quality, manufacturing, regulatory, clinical, marketing, R&D device designers, supply chain, vendors, and kitting centers – across geographies -- to ensure project success. Build Quality into all aspects of product development and support by maintaining compliance to all quality requirements and leading improvements and development of solutions that make it easier for the organization to maintain compliance in complex areas (such as ever-evolving regulatory requirements worldwide). Support audits, non-conformances and CAPAs as needed. Lead small- scale Packaging/Labeling projects or co-manage large-scale programs to drive changes across the portfolio.
Skills:
packaging engineering, medical device, iso 9001, iso 13485
Top Skills Details:
packaging engineering
Additional Skills & Qualifications:
B.S. degree in Packaging, Industrial, Mechanical engineering, or applicable technical field. 3+ years of experience in a highly regulated industry.
Experience Level:
Intermediate Level
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Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.