Lead Medical Device Software Systems Engineer

Stryker; Grand Rapids (MI); Hybrid; USD 118,000 - 197,000; Full time

Job summary

Stryker is seeking a Senior Staff Software Systems Engineer for our Medical Device division in Grand Rapids/Portage, MI. The role focuses on leading software-driven system development, ensuring traceability from stakeholder needs through software requirements and verification, in strict compliance with design controls.

Responsibilities include defining high-level software requirements, driving architecture decisions, and coordinating with Quality, Regulatory, and Agile teams to deliver safe,

Qualifications

• Bachelor's degree in Software Engineering/ Computer Science or related discipline and 6+ years of work experience.
• Experience with complex software-driven medical device systems.
• Familiarity with design controls and quality system requirements.

Responsibilities

• 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.

Skills

Software engineering

System architecture

Traceability

Regulatory compliance

Education

Bachelor's degree in Software Engineering/ Computer Science or related discipline

Tools

Requirements Management Tools

System Modeling Tools

Job description

Stryker is seeking a Senior Staff Software Systems Engineer for our Medical Device division in Grand Rapids/Portage, MI. The role focuses on leading software-driven system development, ensuring traceability from stakeholder needs through software requirements and verification, in strict compliance with design controls.

Responsibilities include defining high-level software requirements, driving architecture decisions, and coordinating with Quality, Regulatory, and Agile teams to deliver safe,