Job Description
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%
