Staff Software Design Quality Engineer
Stryker
Summary
Stryker is seeking a Staff Software Design Quality Engineer to support our Smart Care division's growing portfolio of digital, connected, cloud-based, and software-enabled healthcare solutions. This role sits at the intersection of software development, quality systems, risk management, and regulatory compliance, partnering closely with software engineering teams to ensure quality is integrated throughout the software development lifecycle. This is a strategic quality engineering role focused on process excellence, compliance oversight, and risk management rather than software testing or test execution.
Job description
What You Will Do
- Lead software quality and compliance activities for cloud-based, connected, Software as a Service (SaaS), and software-enabled medical technologies.
- Guide product development teams through software development lifecycle requirements, quality system processes, and design control documentation.
- Conduct risk assessments, software Failure Modes and Effects Analyses (FMEA), security risk reviews, and change-impact assessments throughout product development and sustaining activities.
- Review quality deliverables, design documentation, and release readiness packages to ensure compliance with applicable quality and regulatory requirements.
- Develop and improve quality procedures, work instructions, templates, and governance frameworks that support scalable software development practices.
- Support audit and inspection readiness activities, including evidence collection, gap assessments, corrective actions, and compliance monitoring.
- Integrate quality and risk management practices into Agile, DevOps, and continuous integration/continuous deployment environments.
- Partner with engineering, cybersecurity, regulatory, privacy, information technology, and operations teams to drive quality-focused decision-making and process improvement initiatives.
What You Will Need
Required Qualifications
- Bachelor's degree in Engineering, Sciences, or a related technical discipline.
- Minimum 4 years of experience in a regulated industry within Research & Development, Quality, Software Engineering, Information Technology, Healthcare IT, or Systems Engineering.
- Experience working within software development lifecycle methodologies, including Agile, SAFe, and/or Waterfall.
- Experience with software risk management, software Failure Modes and Effects Analysis (FMEA), security risk assessments, defect management, software verification, and software validation activities.
Preferred Qualifications
- Master's degree in Computer Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related technical field.
- Experience supporting regulated software products, including Software as a Medical Device (SaMD), software-enabled medical systems, digital health, or telehealth solutions.
- Experience with medical device quality and regulatory standards, including FDA regulations, IEC 62304, IEC 82304, or related frameworks.
- Experience supporting cloud, mobile, artificial intelligence/machine learning, Amazon Web Services (AWS), Microsoft Azure, Google Cloud Platform (GCP), iOS, or Android technologies.
Requirements
- Bachelor's degree in Engineering, Sciences, or a related technical discipline.
- Minimum 4 years of experience in a regulated industry within Research & Development, Quality, Software Engineering, Information Technology, Healthcare IT, or Systems Engineering.
- Experience working within software development lifecycle methodologies, including Agile, SAFe, and/or Waterfall.
- Experience with software risk management, software Failure Modes and Effects Analysis (FMEA), security risk assessments, defect management, software verification, and software validation activities.
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.