Join Stryker as a Senior Software Quality Engineer specializing in Design Assurance to lead quality initiatives for innovative medical software and devices. You will play a critical role in ensuring compliance with regulatory standards and driving excellence in product development for healthcare solutions.

Stryker is a global leader in medical technology, and we are seeking a talented Senior Software Quality Engineer in Design Assurance to join our dynamic team in Portage, Michigan. In this pivotal role, you will be responsible for overseeing the quality assurance processes for software components integrated into our medical devices and systems. Your expertise will ensure that all products meet stringent regulatory requirements while maintaining the highest standards of safety and efficacy.

Key responsibilities include developing and implementing quality plans for software design, conducting risk assessments, and leading verification and validation activities. You will collaborate closely with software engineers, product managers, and regulatory affairs teams to identify potential issues early in the development cycle and implement robust mitigation strategies. Additionally, you will support audits, prepare documentation for submissions, and contribute to continuous improvement initiatives to enhance overall product quality.

This position offers the opportunity to work on groundbreaking healthcare innovations that impact patient outcomes worldwide. If you have a passion for quality engineering in a fast-paced, regulated environment and a commitment to excellence, we encourage you to apply and help shape the future of medical technology at Stryker.

• Bachelor's degree in Computer Science, Software Engineering, or a related field; advanced degree preferred
• 7+ years of experience in software quality assurance, with a focus on design assurance in a regulated industry like healthcare
• Strong knowledge of FDA regulations, ISO 13485, and software development lifecycle (SDLC) standards
• Proficiency in risk management, including FMEA and hazard analysis
• Experience with software testing methodologies, tools (e.g., JIRA, Selenium), and validation processes
• Excellent problem-solving skills and attention to detail
• Ability to collaborate cross-functionally with engineering, regulatory, and product teams
• Certification in quality engineering (e.g., CQE) or Six Sigma is a plus

• Competitive salary and performance-based bonuses
• Comprehensive health, dental, and vision insurance coverage
• 401(k) retirement savings plan with company matching
• Generous paid time off, including vacation, sick days, and holidays
• Professional development opportunities, including tuition reimbursement and training programs
• Employee stock purchase plan and wellness incentives
• Flexible work arrangements and remote options where applicable
• Access to cutting-edge medical technology and innovation resources