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 software IT products, serving as a 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

• Manage the design control process, including requirements development, design planning, verification, validation, and design transfer.
• Leads requirement decomposition and traceability (user -> system -> subsystem)
• Ensure user requirements are accurately translated into system requirements, designs, and test scenarios.
• Collaborate with the Product Manager and Product Owners  Program Manager to develop user and system requirements and define/enforce architectural guidelines.
• Overseas design changes and lifecycle  maintenance.
• Provide oversight and guidance for resolving field and manufacturing issues, including root cause investigation, risk assessment, and appropriate CAPA actions.
• Maintains design history files (DHF) and ensures compliance with regulatory documentation expectations.
• Execute Risk Management procedures to ensure compliant and effective mitigation of product risks.
• Ensure product designs comply with relevant international standards and regulations.
• Ensure product security is maintained, and necessary security measures are included in product/process (DEPS artifacts, Security TDRs, Security Risks Assessments, et)
• Supports product audits and regulatory submissions (eg 510k, MDR) as the engineering lead.
• Acts as the technical integrator across functions, working closely with Product Management, Program Management , Quality Assurance, Regulatory Affairs, Security, Manufacturing, Engineering, etc.

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

• Familiarity with Software Development Lifecycle (SDLC)
• Familiarity with quality systems such as ISO 13485.
• Knowledge of risk management (ISO 14971).
• Background in verification/validation for clinical devices.
• Demonstrated ability to analyse and resolve problems.
• Established project management skills.

Additional Information