Stryker Staff 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.
Effective communicators. People who regularly share relevant status updates and effectively articulate issues and recommendations to stakeholders and senior management.
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. We are a very diverse group with an impressive set of experiences from biotech and high-tech companies. If you want to build a rewarding career with an innovative company, then come join us now!
Staff Software Quality Engineers 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.
As a Staff 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.
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 read on!
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 through out the SDLC & NPD process.
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 be responsible for Software test and quality assurance including software verification strategies, test scripts and traceability to requirements.
You will manage, lead and/or assist in resolving nonconformities and corrective actions/preventive actions (CAPA)
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
5 years’ experience working in a highly regulated environment, software related role, engineering, quality, manufacturing or new product development highly preferred.
Experience as a Quality Engineer (QE) in a regulated design environment highly preferred.
Knowledge of medical device product development life cycle, including risk management and design/ process verification & validation and computer software validation 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.
Proven ability to develop and troubleshoot complex software systems that run in mixed environments.
Work From Home: Regularly scheduled days
Travel Percentage: 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com
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