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Senior Advance Quality Engineer- Software

3 months ago

Gurgaon, Haryana, India Stryker Full time

Why consider engineering opportunities at Stryker?

At Stryker, we are committed to enhancing lives by dedicating ourselves to the research and development of cutting-edge medical device solutions. As part of our engineering team, you will engage in impactful work that leverages advanced technologies to elevate the standard of healthcare. Join our collaborative environment filled with exceptionally talented individuals, where you can contribute to pioneering medical technology innovations. You will also have ample room for personal and professional growth, supported by our development-focused culture.

Looking for more reasons to explore a career at Stryker? Discover these 8 compelling incentives to become a part of our engineering team:

Key responsibilities and tasks

  • Implement Risk Management according to ISO14971 to ensure product safety and efficacy.
  • Conduct design and risk management reviews at critical project stages.
  • Collaborate with R&D on Electrical and Embedded system advancements to ensure safety and quality.
  • Lead DHF / DMR Reviews for Software / Electrical / Embedded projects.
  • Assist in Computer System Validations and Process Validation processes as needed.
  • Engage in cybersecurity risk assessment activities.
  • Contribute to V&V procedures to guarantee product compliance, safety, and reliability.
  • Review Clinical Evaluation and Regulatory documents related to Quality aspects.

Qualifications and skills needed

  • Demonstrated application of Medical Device Risk Management per ISO 14971.
  • Proficiency in utilizing Risk Analysis methodologies and tools.
  • Experience with Medical Device Software Development Life Cycle Process (SDLC) as per IEC 62304.
  • Familiarity with Medical Device Electrical/Electronic Hardware Development Life Cycle Process (HDLC).
  • Knowledge of essential documentation throughout Hardware & Software development lifecycles.
  • Understanding of electrical and embedded component functionalities.
  • Knowledge of IEC standards and basic programming languages for embedded software.
  • Familiarity with Quality Management Systems for Medical Devices (ISO 13485, 21 CRF 820).

Educational requirements

  • Bachelor's or Master's degree in Software/Electrical/Embedded Engineering.
  • Experience level: 4-8 years

About StrykerStryker stands as a renowned global pioneer in the field of medical technologies, tirelessly working with our partners to advance healthcare standards. Our innovative product range across MedSurg, Neurotechnology, Orthopaedics, and Spine segments is designed to enhance patient well-being and healthcare efficacy. Collaborating with customers worldwide, Stryker positively impacts over 130 million patients annually.