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Sr Software Quality Design Engineer

5 - 7 years

6 - 10 Lacs

Gurgaon

Posted:3 months ago| Platform: Naukri logo

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Skills Required

Software design ISO 13485 Document review ISO Analytical Software development life cycle software quality New product development Risk management SDLC

Work Mode

Work from Office

Job Type

Full Time

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%

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Sgtc India
www.sgtcindia.com

Information Technology

Noida

51-200 Employees

70 Jobs

    Key People

  • Rajesh Kumar

    CEO

  • Anita Singh

    CTO

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