Sr Software Quality Design Engineer

Work Flexibility: Hybrid

Position profile

Sr Software Design Quality Engineer

Responsibilities and duties

• Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of ECO/ECR.
• Effective change control for NPD and Sustaining Products.
• Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
• Participate in design reviews during various phases of NPD.

• Work with team to develop robust verification, Design validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
• Sound knowledge of IEC 62304: Medical device Software - Software life cycle processes. This also includes good exposure to all the phases of Software development life cycle (SDLC).
• Exposure to any Programming language & on Software Testing concepts.
• Design And User Validation exposure. Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.

Experience/skills required

• Bachelors in Computers/ IT/ Electronics.
• Good analytical and problem-solving skills.
• Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
• 5-7 years of relevant work experience.
• Experience on NPD process and various phases of new product development.
• Knowledge of ISO 14971, IEC 62304, IEC 62366, 60601-1 family of standards.
• Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
• Expert-level knowledge of current industry standards for New Product Development and risk management practices.
• Strong knowledge of Quality Concepts (e. g. CAPA, Audits, Statistics).
• Strong interpersonal skills, written communication and negotiations skills.

Travel Percentage: 50%