Principal Software Design Quality Engineer (Remote)

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Written by AI from the job title and company, not by Stryker, so some details may not match this job. The employer's own page has the real description.

Job Overview

The Principal Software Design Quality Engineer at Stryker will be responsible for ensuring the highest quality and compliance of software products throughout their development lifecycle. This role involves designing robust quality engineering practices, formulating test plans, leading validation efforts, and collaborating with cross-functional teams to deliver safe and effective medical software solutions. The selected candidate will play a crucial role in influencing software design decisions and guaranteeing that products meet stringent regulatory requirements while also aiming for continuous improvement in processes and quality standards.

Job Responsibilities

• Develop and implement software quality engineering strategies and processes to ensure high-quality product delivery.
• Design, execute, and oversee validation plans for software applications in compliance with industry regulations.
• Collaborate with software development teams to integrate quality practices into the software development lifecycle (SDLC).
• Conduct technical reviews and provide input on software design specifications and architectural documents.
• Identify, document, and manage software defects, driving them to resolution while advocating for best quality practices.
• Lead root cause analysis and corrective actions for defects found during testing or post-release.
• Provide mentorship and guidance to junior quality engineers, promoting a culture of quality within teams.
• Assist in regulatory audit preparations and activities, ensuring compliance with both internal policies and external regulations.

Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, or a related field; Master’s degree preferred.
• A minimum of 7 years of experience in software quality assurance/engineering, preferably in the medical device industry.
• Proven experience in software validation and testing methodologies, including automated testing tools.
• Strong understanding of regulatory standards such as ISO 13485, FDA regulations, and IEC 62304.
• Excellent analytical skills with a keen attention to detail and a problem-solving mindset.
• Ability to work effectively in a fast-paced, collaborative team environment.
• Strong verbal and written communication skills, with the capability to articulate complex concepts to technical and non-technical stakeholders.

Technologies & Tools

The Principal Software Design Quality Engineer will leverage various technologies and tools including test management software, automated testing frameworks (such as Selenium or TestComplete), version control systems (like Git), and continuous integration/continuous deployment (CI/CD) tools. Familiarity with programming languages such as Python, Java, or C# and experience with requirement traceability tools will also be essential for this role.

Ideal Candidates

Ideal candidates for the Principal Software Design Quality Engineer position will exhibit a robust technical acumen alongside a commitment to quality and regulatory excellence. They should possess strong leadership qualities, fostering collaboration and team engagement. A passion for technology, innovation, and the advancement of healthcare solutions will be critical. Candidates should also demonstrate a proactive approach to problem-solving and possess the ability to navigate complex software challenges with resilience and adaptability.