Design Quality Engineer - Software
Gurugram, Array, IN
3d ago

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 : https : / / www.strykercareersblog.

com / post / 8-reasons-to-join-strykers-engineering-team

Who we want :

  • Dedicated achievers : People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Persuasive influencers : People who understand market positioning and can use their relationship skill and depth of knowledge to secure buy-in, cooperation, and loyalty.
  • Hard-working winners : Confident, competitive and results-oriented salespeople who create a track record of success.
  • Collaborative partners : People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
  • Analytical problem solvers : People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • What you will do :

  • Primarily responsible for Risk Management, Design Inputs review, Design History File Documents review, Design Output Document review, Test log test plans, Software verification and Validation.
  • Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
  • Responsible to ensure provisions of software life cycle processes are followed and associated reviews are conducted.
  • DQA shall drive coordination with different departments (such a R&D, Testing, Regulatory, Post Market Quality) to ensure the resulting part / product / process is safe, compliant and effective
  • Conduct design reviews during various phases of NPD.
  • Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
  • Work with team to develop robust software architecture as per quality and regulatory requirements.
  • Expert-level knowledge of current industry standards for software engineering and risk management practices ideally from the domain of safety critical applications
  • Demonstrated ability to apply software and system quality management practices in efficient and effective ways while being compliant.
  • Solutions-based approach to quality engineering, wants to provide added value" ( quality police attitudes won’t survive in our culture).
  • Good interpersonal and communication skills.
  • What you need :

  • Education : B.Tech / BE in Computer Science or Electronics Engineering
  • 2-5 Years’ experience in new product development focused on quality engineering related activities. Strong preference given to medical device industry experience)
  • Experience on Medical Device Software Development Life Cycle Process (SDLC) IEC 62304
  • Experience on NPD process and various phases of new product development.
  • Knowledge of ISO 14971, IEC 62304, 60601-1 family of standards.
  • Understanding of Quality Management Systems. (ISO 13485, 21 CRF 820, ISO 9001)
  • Familiarity with basic programming language, embedded software & tools.
  • Ability to review Defects.
  • Ensure that software, mechanical, electronic, and material / implant engineering follow the same approaches, wherever possible, to ensure seamless cooperation between these diverse disciplines and their associated system responsibilities.
  • Provide expertise in establishing good specifications and protocols like requirements, architecture, detailed design, verification & validation planning, etc.
  • Establish world class risk methodologies for complex systems based upon existing corporate / divisional approaches.
  • Conduct and moderate all kind of Design Reviews (e.g. SRS Reviews, source code reviews, etc.).
  • Establish overall system test design in cooperation with test engineering.
  • Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.
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