Job Description Summary

The Lead System Designer ensures that product programs meet all design objectives to satisfy customer and business needs, including features, functionality, quality, reliability, serviceability, manufacturability, regulatory compliance, and cost. This role is crucial in the design and maintenance of our diagnostic ultrasound products, serving as the technical design lead. The Lead System Designer oversees and approves new product designs and ensures the ongoing maintenance and support of the product's design history, with a strong emphasis on safety and risk management.

Job Description

Roles and Responsibilities

• Lead the design team and manage the design control process, including requirements development, design planning, verification, validation, and design transfer.
• Ensure user requirements are accurately translated into system requirements, designs, and test scenarios.
• Collaborate closely with the Product Manager and Program Manager to develop user requirements and define/enforce architectural guidelines.
• Provide oversight and guidance for resolving field and manufacturing issues, including root cause investigation, risk assessment, and appropriate CAPA actions.
• Own overall product quality, focusing on product architecture and design decomposition with an emphasis on platforming, re-use, and reliability.
• Execute Risk Management procedures to ensure compliant and effective mitigation of product risks.
• Ensure product designs comply with relevant international standards and regulations. Implement design strategies such as requirement management, reliability testing, FMEA, and CAPA, demonstrating compliance with standard processes.

Required Qualifications

• Bachelor’s degree in Engineering or Science.
• Proven ability to lead a global product development project.
• Proficient in business-level English communication.
• Strong oral and written communication skills.

Desired Characteristics

• Demonstrated ability to analyze and resolve problems.
• Established project management skills.

Additional Information