Senior Software Quality Engineer

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

• 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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