Senior Staff Engineer, Design Assurance - Sustaining

Stryker Employment Company - Mahwah, NJ

Full-time - Senior

Remote - Mahwah, NJ

About the position

The Senior Staff Engineer, Design Assurance - Sustaining at Stryker is responsible for leading risk management and usability activities for Joint Replacement products. This role ensures compliance with ISO standards while collaborating with cross-functional teams to address emerging issues and maintain product quality. The position involves directing sustaining engineering strategies, optimizing manufacturing processes, and supporting continuous improvement initiatives for orthopedic products.

Responsibilities

• Lead and evaluate risk management and usability activities for Joint Replacement products in accordance with ISO standards.
• Define strategy and partner with technical and managerial leaders on emerging issues.
• Manage Joint Replacement Lifecycle Management including Product Transfers and Supplier Initiated Change Requests.
• Evaluate and influence guidance documents and internal training for cross-functional teams.
• Present externally in audits regarding risk management files.
• Drive collaboration with cross-functional partners to solve technical problems related to existing orthopedic products.
• Represent Design Assurance in global initiatives to improve cost and manufacturing of Stryker devices.
• Identify, evaluate, and lead continuous improvement projects within the Design Assurance team.

Requirements

• Bachelor's degree in engineering or science.
• 6+ years of related experience in quality, engineering, and/or risk management.
• Experience in a highly regulated industry.

Nice-to-haves

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