Senior Software Quality Engineer
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Job Location:
Portage, WI - USA
Monthly Salary:
$ 89300 - 148800
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
As a Senior Software Quality Engineer you will drive execution of the Software Development Life Cycle (SDLC) for products developed by the Ortho Tech Orthopaedic Instruments (OI) business. As a member of a cross-functional design team you will partner closely with engineering product and regulatory stakeholders to ensure the efficient delivery of secure safe and effective software through disciplined application of our software quality processes.
Workplace flexibility: This role is hybrid in Portage MI with the expectation to be in office 3-4 days a week.
Check out our portfolio: Orthopaedic Instruments
What You Will Do:
Guide New Product Development (NPD) teams through quality system requirements ensuring compliance with internal procedures FDA ISO and other regulatory standards.
Partner with cross-functional project teams to lead product and/or process planning design and development activities
Provide quality and engineering input throughout the SDLC with primary focus on requirements definition test planning/execution security risk management and regulatory compliance.
Partner with cross-functional engineering teams (software electrical mechanical and industrial design) to ensure embedded software meets product and system design requirements.
Manage and oversee software builds release change control and configuration management ensuring traceability and compliance.
Lead software defect management activities across all phases of the software development lifecycle including tracking root cause analysis and resolution.
Perform requirements analysis design review code review threat modeling and cybersecurity and safety risk assessments aligned with design controls.
Plan drive and document verification and validation activities including test strategies test cases and quality metrics.
What You Need
Required:
Bachelors degree in Computer Science Computer Engineering Software Engineering or related discipline.
Minimum of 2 years of relevant experience working in a highly regulated environment software development or software quality.
Proficiency in risk analysis software architecture and design and software verification.
Preferred:
Experience in medical device development and Software in a Medical Device (SiMD) Design History Files (DHFs).
Proficiency in programming embedded systems and related technologies (C/C Python Yocto device drivers SPI I2C)
Knowledge of FDA QSRs ISO 13485 Design Control Procedures IEC 62304 and ISO 14971
Experience with tooling for SDLC automation such as Jira Gitlab Ansible Ketryx Jama and Artifactory.
Cybersecurity certifications (e.g. CSSLP SSCP) or demonstrated experience in secure software development threat modeling or security risk analysis
$89300 - $148800 USD Annual
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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 contractors legal duty to furnish information.Required Experience:
Senior IC
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
