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Senior Advance Quality Engineer- Software

5 months ago

Gurugram, India Stryker Full time

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: 

Responsibilities and duties

Conduct Risk Management per ISO14971 to ensure the safety and effectiveness of product.Conduct design reviews & risk management reviews as required during various project phases. Work with R&D during Electrical/ Embedded developments (Electrical & electronic hardware development and Software development) to provide inputs & safety. Participate and conduct DHF / DMR Reviews for Software / Electrical/ Embedded developments.Support Computer System Validations & Process Validation as required.Support in conducting cybersecurity risk assessment documents.Support in V&V to ensure product compliance, safety, reliability & effectiveness.Review of Clinical Evaluation Reports, Post Market Clinical Follow up & Safety documentation and Regulatory documentation on Quality aspect.

Experience/skills required.

Practical implementation of Risk Management of Medical Device per ISO 14971.Experience with Risk Analysis tools and techniques.Experience on Medical Device Software Development Life Cycle Process (SDLC) IEC 62304.Experience on Medical Device Electrical/Electronic Hardware Development Life Cycle Process (HDLC).Understanding of various documentation required during Hardware & Software development lifecycle.Understanding of electrical & embedded component’s working principle and functionality.Familiarity with IEC 60601-1 family of standards.Familiarity with any basic programming language, embedded software & tools.Understanding of Quality Management Systems for Medical Devices. (ISO 13485, 21 CRF 820).

Education

B. Tech / B.E / M. Tech / – Software/ Electrical/ Embedded EngineeringExperience: 4-8 years

About StrykerStryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at