Staff Quality Engineer, Software in Kalamazoo, MI at Stryker Corporation

发布日期: 2/9/2020



Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Software Advanced Quality Engineer located in Kalamazoo Michigan

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.

Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.

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

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do:

  • Take ownership for the testing effort of Embedded Software of medical devices.
  • Take ownership of development testing, integration testing as well as system verification.
  • Participate in Test Planning, system test strategy, methodology, and creation of system integration test cases and make them traceable back to the system requirements, feature lists and design documents.
  • Work with design engineers to assess the risks associated with the software being developed and propose solutions to mitigate the risks associated with the software and ensure that risks associated with the software are properly linked with the risk assessment for the medical device.
  • Develop a software validation test strategy and ensure that the strategy properly challenges all aspects of the software design.
  • Execute or delegate software validation tasks to ensure the developed software meets the requirements outlined within the software requirements documentation.
  • Develop and maintain validated build environments for production and late prototype software.
  • Challenge the design of the software through participation in code reviews and design reviews to ensure that the software utilizes Stryker and industry standard practices and that the software meets the requirements of the medical device.
  • Help guide new product development teams through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
  • Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust software solutions.
  • Provide input throughout the new product development process from a quality perspective.
  • Educate new product development teams on the use of risk management tools, statistical methods, design and process control activities, and sound software validation test planning to help drive quality upfront in new product development.
  • Involvement in mentorship and training of others on QA topics

What you need:

  • B.S. in Software Engineering, Electrical Engineering, Computer Science, Computer Engineering, or related field or equivalent discipline
  • 5+ years’ experience in a software development, validation or quality engineering role within a software regulated industry (e.g. medical device, pharmaceutical, aerospace)
  • M.S. in computer engineering or electrical engineering with focus on embedded software development is desired
  • Focused course work or on the job training for embedded software development and/or testing is desired
  • Experience with a regulated industry experience such as Medical, Aerospace, Defense, Communication, and/or automotive embedded software control experience is desired
  • Experience in a Quality role familiar with FDA and ISO requirements.
  • Working knowledge of Risk Analysis, GD&T, SPC, Root Cause Analysis, Statistics and practical applications
  • Experience with one of the following C#, C++/C, Python, etc.
  • Well versed with writing test plans and test cases document.
  • Experience with DSO, logic analyzer, Debugger, and similar tools
  • Exposure to test management tools like Jira, Bugzilla etc.

Work From Home: Not available

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.