Staff Engineer, Design Assurance

Work Flexibility: Hybrid

What you will do:

• Lead risk management and usability activities for Joint Replacement products currently in the field in accordance with ISO 14971 and IEC 62366.
• Define strategy and execute on emerging issues (NC/CAPA, Regulatory Requests), Joint Replacement Lifecycle Management (Product Transfers, Supplier Initiated Change Requests), and Base Business Requests (Risk Management Periodic Review, EUMDR Compliance, Health Risk Assessments).
• Create and present guidance documents and internal trainings to cross functional teams on areas of experience for risk management and usability, as well as present externally in audits on our risk management files.
• Collaborate with cross functional partners from various groups including Product Development, Regulatory, and Clinical to solve technical problems regarding our existing orthopedic products
• Be a part of global initiatives to improve the cost and manufacturing on Stryker devices.
• Identify and lead continuous improvements projects within the Design Assurance team to implement new efficiencies into daily deliverables and large-scale tasks
• Be a part of a global team that drives engineering activities in the maintenance of orthopedic products to ensure the highest level of product quality and ensure compliance to the company’s quality system and external standards.
• Contribute to a team with whose mission is to efficiently drives rigor in Sustaining activities through creative problem solving and ensures market continuity of safe and effective products. 

What you need:

Required:

• Minimum of 4 years experience in quality, engineering and/or risk management in a highly regulated industry.
• Bachelor’s Degree in engineering

Preferred:

• Experience with ISO 13485, ISO 14971 and IEC 62366.
• Experience in quality concepts (risk management, audits, NC/CAPA, HRAs).
• Strong interpersonal skills, written communication, and oral communication.

Travel Percentage: None

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