Sr Staff Engineer - Software Quality Assurance

Stryker Global Technology Center Pvt Ltd. (Gurugram, HR, India) 16 days ago

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 skills 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:

  • Define User Needs by translating the voice of customer feedback to design user needs. 
  • Define Software Requirement Specifications and ensure they are testable, unambiguous and cover the full functionality of the code and user needs. 
  • Conduct Product and Cybersecurity Risk Assessments by working with current product quality data, FDA MAUDE database, and other sources to find issues with currently marketed products, assess clinical risk to customer and patients, and offer design recommendations to improve product safety, reliability, durability and performance. 
  • Provide risk assessment for software defects and drive resolution by using a risk-based approach. 
  • Provide Usability / Human Factors Engineering to Identify areas for improving intuitive use, usability of products through usability protocols, formative studies - executing studies with actual users (surgeon, nurse, technician, specialists). 
  • Lead product quality related projects. Supports the business in addressing and solving quality problems. Able to review Code and debug solutions of simple Complexities.
  • Able to Lead System Design Validation activities for NPD and Sustaining Projects.
  • Assists and mentors the unit quality engineer in the trending and analysis of quality data (e.g. complaints, Tech Support trouble tickets, Pareto charts, scrap, warranty return rate, etc.) and provides guidance to address issues as appropriate.
  • Authors and reviews procedures to ensure GMP and ISO 13485 compliance.
  • Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.
  • Exposure to any Programming language & on Software Testing concepts.
  • Partner with cross-functional/cross –cultural teams to develop regulatory guidelines , procedures and build security and safety into the design code to ensure products are safe and effective for the end user.
  • Post Quality Engineering support including Complaint Handling, NC, CAPA.
  • Provide inputs for NPDP for adherence to QMS and Good Documentation practices. Key reviewer of project documentation relating to design, compliance, and product testing. Final approver on product launch documentation, sending request to senior management to approve product release for sale.
  • May interact, by telephone or in person, with customers to resolve product issues as part of support escalation model.
  • May require Visit to clinical facilities and health care providers (HCP) to gather use data to further develop and improve clinical knowledge, use cases, and potential applications for medical devices

What you need:

  • 12 + years of work experience with strong exposure to Software development life cycle & validation process.
  • BE/BTech or Equivalent Software or Electronics/Electrical (Preferably Software) with experience in quality role in engineering /manufacturing environment
  • Able to lead risk assessment for medical devices as per ISO 14971. Strong experience of in Risk management, Risk Table creation & Analysis, FMEAs, Quality Inspection procedure, Literature Review, Device Master Record, Design Validation & Quality Training plan.
  • Expert in IEC 62304 standard for Medical device software.
  • Knowledge of IEC 606061-1 family of standards will be a plus.
  • Knowledge of Human Factors Engineering/ Usability Engineering IEC62366.
  • Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.
  • Excellent analytical skills.
  • Strong experience in Documentation, Review & Reporting areas.
  • Excellent interpersonal communication skills.
  • Demonstrated software or electrical problem-solving skills.
  • Expert in Software development life cycle & validation process.
  • Understanding of Quality Management Systems for Medical Devices.
  • Strong experience in Documentation, Review & Reporting areas.
  • Responsible for initiating, reviewing (Includes Design reviews & Phase Reviews), documenting and approving Engineering Change Orders (ECO’s) and ECR’s.
  • Work with engineering & manufacturing teams to develop robust validation strategies to ensure product safety and reliability.
Work From Home: OccasionalTravel Percentage: None
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Sr Staff Engineer - Software Quality Assurance

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