Senior Packaging Engineer - PSE in Elstree at Stryker Corporation

Date Posted: 10/11/2019

Job Snapshot

Job Description

  • Provide Packaging Subject Matter Expertise for Sterile Packaging of Medical Device Implants.
  • Perform remediation of existing sterile packaging and cleaning for Medical Device implants to comply with ISO11607-1 and ISO11607-2 (Packaging For Terminally Sterilized Medical Devices).
  • Work closely with all cross functions in the business, especially core project teams, marketing, regulatory, quality and operations to support the business objectives.
  • Lead the post launch assess phase activities of all product packaging design solutions for products.
  • Provide technical support to both the Quality Assurance and Regulatory teams to help investigate and recommend solutions to any package design related issues and the completion of technical assessments/SofHA’s where applicable.
  • Own all package design related NCR/CAPA’s for the Packaging Group and ensure timely closure of all issues in line with procedure guidelines.
  • Conduct VOC (voice of the customer) for packaging and transfer it into appropriate action with regards to packaging design ensuring proactive and satisfactory closure with the customer
  • Provide technical support to Packaging Operations to help troubleshoot, investigate, and recommend solutions to any package related issues.
  • Provide technical support to the Supply Chain team on any package related supplier issues or re-sourcing activities.
  • Determine, coordinate and execute physical package testing to ensure product and package integrity. 
  • Write and perform test protocols for evaluations and validation.
  • Interface with the Global PSE Packaging Group and other Advanced Operations team members both locally and globally, Quality Assurance / Regulatory and Operations Teams to ensure equivalency of approach in Equipment, Processes and Validation techniques.
  • Maintain an overview of state-of-the-art technologies within medical device packaging through understanding of technology, clinical practice, regulatory environment and competitive and intellectual property landscape assessment.
  • All other duties as assigned.

•Bachelor of Science Degree in Packaging, Engineering or Science is required.

•The individual must have a minimum of 5-10 years relevant packaging experience within a regulated environment – FDA, ISO etc.

  • Business understanding of operations and their individual impact is essential.
  • Strong communication skills with both Internal and external agents.
  • Flexibility essential with strong project management skills.
  • The individual should enjoy working in a dynamic and results motivated team based.
  • Strong cross-functional leadership skills and ability to influence matrixed teams.
  • Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
  • PC literate and strong knowledge of Microsoft Office tools are essential.

•Thorough knowledge of primary and secondary component materials, systems, and converting processes.

  • Broad understanding of Design Control process and experience developing products under these guidelines.

Work From Home: No

Travel Percentage: Up to 25%

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