Senior Staff Software Systems Engineer- Medical Device

Stryker; Grand Rapids (MI); On-site; 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

Senior Staff Software Systems Engineer- Medical Device

Hybrid - Grand Rapids, Michigan, United States · Portage, Michigan, United States

Aug 24, 2026

$118,000 - $196,700/year

Work Flexibility: Hybrid

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.

What You Will Do

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 & 6+ 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 resourcesfor software implementation.

Understanding of regulatory and compliance requirementswithin the SDLC.

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

$118,000 - $196,700 USD Annual

Travel Percentage: 30%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is a global leader in medical technology, providing innovative solutions in MedSurg, Neurotechnology, and Orthopaedics to enhance patient care and outcomes.

Medical Equipment Manufacturing Manufacturing