Senior Staff Software Systems Engineer- Medical Device

Stryker; Portage (MI); On-site; USD 118,000 - 197,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

HSA

401(k) plan

ESPP

Job summary

Stryker is seeking a technical leader to guide the development of complex, software-driven medical device systems in the Neurosurgical group. You will align stakeholder needs with architecture and regulatory requirements to ensure traceability from needs to verification.

You will partner with Agile teams, drive integration and validation activities, and mentor teams to deliver high-quality, compliant software solutions for medical devices.

Qualifications

• Requires a Bachelor's degree in software-related field and 6+ years of work experience.
• Experience leading software-driven medical device development programs.
• Ability to translate user and system needs into traceable software requirements.
• Knowledge of design controls and software development lifecycle.

Responsibilities

• Translate user, clinical, and system needs into clear, traceable high level software requirements.
• Contribute to concept development and architecture decisions for complex designs.
• Drive software system integration, verification, and validation to meet safety and quality goals.
• Maintain end-to-end traceability across requirements, architecture, implementation, and testing.
• Coach teams to develop high-quality, testable, compliant requirements.
• Collaborate with Agile teams to prioritize features and enable predictable delivery.
• Work with Quality, Regulatory, PM, and R&D to ensure alignment and execution.
• Support VOC activities and incorporate insights into system design.
• Contribute to DHF documentation and ensure compliance with medical device regulations.

Skills

Software leadership

Systems engineering

Communications

Education

Bachelor's degree in Software Engineering/ Computer Science

Tools

Requirements Management Tools

System Modeling Tools

Job description

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 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.

$118,000 - $196,700 USD Annual

Health benefits

• Medical and prescription drug insurance
• dental insurance
• vision insurance
• critical illness insurance
• accident insurance
• hospital indemnity insurance
• personalized healthcare support
• wellbeing program
• tobacco cessation program

Financial benefits

• Health Savings Account (HSA)
• Flexible Spending Accounts (FSAs)
• 401(k) plan
• Employee Stock Purchase Plan (ESPP)
• basic life and AD&D insurance
• short-term disability insurance

Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.