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:
Bachelor’s 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
$89,300 - $148,800 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 contractor’s legal duty to furnish information.