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.