Staff Engineer, R&D Packaging

Who we want:

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Curious learners. Engineers with an interest in technology advancements who seek out cutting-edge research and information to expand and enhance their ability to develop products.
• Effective communicators. Partners who regularly share relevant status updates and effectively articulate issues and recommendations to stakeholders.

Stryker is hiring a Staff Engineer, R&D Packaging to be in the Model Farm Road, Cork facility.

What you will do:

As a Staff Engineer, R&D at Stryker Neurovascular, you will be a valued member on Product Engineering Packaging teams with responsibilities for design, development of packaging components and artwork design, completion of design verification, shelf-life testing and facilitating label design.

You may support implementation of packaging processes on plant equipment, systems and other fixed assets to a high standard of safety, quality and productivity at the lowest possible cost while maintaining compliance with all applicable regulatory requirements.
 

Main responsibilities include:

• 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 in parts of a major project to drive changes across the portfolio.
• Role-model a high level of service and responsibility in managing a high and varied workload from internal clients and working to tight timelines.
• Independently conceive and develop approaches to problem solving that requires advanced technical knowledge
• Collaborate with other engineering teams to integrate automated solutions seamlessly.
• Work with development teams across the organization to plan, implement, and track end-to-end automation activities
• Assure testing is appropriately developed and in accordance with the risk level of the item being tested
• Ensure that the processes, facilities, equipment, or systems for which they are responsible are compliant, capable, in control, and maintained in a validated or qualified state.

What you will need:

• B.S. degree in Packaging, Industrial, Mechanical engineering, or applicable technical field.
• 4+ years of experience in a highly regulated industry.
• Demonstrated experience in medical device, biotech, or pharmaceutical packaging design development desired.
• Demonstrated experience in resolving design and process related packaging issues on commercial products.
• Functional knowledge of Design Controls and Industry standards in Packaging Design and Testing (11607, ASTM, ISTA).
• Experienced in writing and execution of Installation Qualification, Operational Qualification, and Performance Qualification (IQ, OQ, PQ) for manufacturing and print equipment.
• Knowledge in database driven Labeling Systems, label and IFU development.
• Strong interpersonal skills, technical and project management capabilities to develop aspects of assigned projects on time and within budget.
• Demonstrated experience in validation, process improvement and qualification of sterile medical device packaging.
• Experienced in Design of Experiments, Statistical Analysis, interpretation, and communication of data.
• Experienced in implementing or managing processes where automated technology is used to perform tasks with minimal human intervention.