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Stryker Software Quality Engineer in Shirley, Massachusetts

Who we want

  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

  • Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do

Stryker is one of the worlds’ s leading medical technology companies, dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care.

As a Software Quality Engineer will be working with cutting edge medical imaging and robotic technologies and medical devices. Your work will help bring new medical devices to market by providing guidance to the development team through the Software Development and New Product Development processes.

As a Software Quality Engineer you are responsible for quality system support for R&D projects; generation and/or review of software documentation; provide inputs to software R&D designs; develop test strategies for software systems; improve quality processes as they apply to software systems.

If you are excited by opportunities that help develop and execute software quality assurance through verification strategies and test scripts, ensuring that documentation is accurate and supports regulatory submissions then please APPLY NOW!

  • You will be responsible for the complete life cycle of a new/modified software product, from research and design to implementation, training and support.

  • You will co-develop software solutions by studying information needs; conferring with users; studying systems flow, data usage, and work processes; investigating problem areas; by developing documentation, flowcharts, layouts, diagrams, charts, code comments and clear code while following the software development lifecycle.

  • You will partner with Product Development to define requirements that will ensure appropriate level of rigor to software validation

  • You will lead Risk Management activities throughout the product development life cycle. Perform formal risk analysis, develop software risk control measures and mitigations, and create SFMECA in support of risk management.

  • You will partner with PD to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria

  • Provide guidance to the development team through Software Development and New Product Development process including demonstrating understanding of software lifecycle methodologies (e.g. Waterfall, Agile).

  • Responsible for Software test and quality assurance including software verification strategies, test scripts and traceability to requirements.

What you need

  • Bachelor's degree in Engineering, Computer Science, Physics or related discipline.

  • Prefer CQE certification or equivalent and Six Sigma Green or Black

  • 0+ years’ experience working in a highly regulated environment, software related role, engineering, quality, manufacturing, or new product development highly preferred.

  • Knowledge of medical device product development life cycle, including risk management and design/ process verification & validation and computer software validation preferred.

  • Preferred knowledge of FDA QSRs, ISO 13485 Design Control Procedures, IEC 62304 and ISO 14971

  • Understanding of Software Design, Software Debugging, Software Documentation, Software Testing, Software Development Fundamentals, Software Development Process, Software Requirements preferred.

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