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.
