Staff Software Systems Engineer- Medical Device, Portage, MI

Stryker is seeking a technical leader responsible for guiding the development of complex, software-driven medical device systems. This position supports our Neurosurgical group and operates at the intersection of systems engineering and software development, ensuring alignment among stakeholder needs, system architecture, regulatory requirements, and product implementation. The role also ensures end-to-end traceability from stakeholder needs through software requirements and verification, in full compliance with design controls and the software development lifecycle.

• Translate user, clinical, and system-level needs into clear, traceable high level software requirements.

• Contribute to early concept development and system architecture decisions, driving resolution of complex design challenges.

• Drive software system integration, verification, and validation activities to ensure performance, quality, and safety objectives are met.

• Establish and maintain end-to-end traceability across requirements, architecture, implementation, testing, and defect management.

• Coach and guide teams in developing high-quality, testable, and compliant requirements.

• Partner with Agile software development teams to prioritize features and enable efficient, predictable delivery.

• Collaborate cross-functionally with Quality, Regulatory, Project Management, and multi-disciplinary R&D teams to ensure alignment and execution.

• Support Voice of Customer (VOC) activities and incorporate clinical and customer insights into system design and development.

• Contribute to Design History File (DHF) documentation and ensure adherence to medical device regulations, design controls, and quality system requirements.

What You Need (Required Qualifications)

• Bachelor's degree in Software Engineering/ Computer Science or related discipline & 4+ years of work experience

Preferred Qualifications (Strongly Desired)

• Experience developing and optimizing complex software systems.

• Advanced knowledge of Requirements Management and System Modeling Tools.

• Ability to communicate complex technical concepts and plans clearly.

• Experience influencing SDLC and ALM/traceability processes and best practices.

• Ability to estimate effort, timelines, and resources for software implementation.

• Understanding of regulatory and compliance requirements within the SDLC.

• Knowledge of software analysis techniques, including static/dynamic analysis and code coverage .

$102,600 - $171,000 USD Annual