Principal Engineer, Systems Engineering

Stryker Corporation; Portage (MI); Hybrid; USD 118,000 - 197,000; Full time

Job summary

Stryker Corporation in Portage, Michigan, seeks a Principal Engineer, Systems Engineering to drive large, complex medical device programs using systems thinking. You will align software, hardware, and data teams, delivering safe, high-quality solutions for a connected healthcare environment.

The role requires a bachelor’s in an engineering field, 8+ years in systems engineering or product development, and proven leadership to manage risks and regulatory design controls.

Qualifications

• Bachelor’s degree in a relevant engineering discipline.
• 8+ years in product development or systems engineering.
• Experience in a regulated industry.
• Knowledge of design controls and regulatory frameworks.

Responsibilities

• Lead system architecture, technical strategy, and integration for complex medical device products.
• Translate customer and clinical needs into system-level requirements across software, electrical, and mechanical teams.
• Lead requirements development, allocation, traceability, and verification planning.
• Drive system-level decision making, architecture reviews, and risk assessments.
• Lead cross-functional product development from concept to verification, ensuring safety and quality.

Skills

Systems engineering leadership

Cross-functional collaboration

Regulatory awareness

Stakeholder influence

Risk management

Education

Bachelor’s degree in Systems, Electrical, Mechanical, Software, Biomedical Engineering, or related

Tools

Jama

DOORS

Polarion

MBSE

SysML

Job description

## Principal Engineer, Systems EngineeringApply: Portage, Michigan: Grand Rapids, Michigan: Full time: Posted Today: R573168Work Flexibility: Hybrid or OnsiteStryker is seeking a dynamic and visionary product development leader with a proven track record of leading large, complex product development programs through the application of systems engineering principles. As the technical quarterback, this individual will drive alignment, collaboration, and execution across a multidisciplinary global product line, ensuring teams work cohesively toward shared objectives while delivering innovative solutions that improve patient care. As medical technologies continue to evolve, our products must operate seamlessly within broader healthcare ecosystems and enabling technology platforms. This leader will be responsible for defining and overseeing system-level architectures, ensuring robust integration across hardware, software, data, connectivity, and partner technologies. They will champion a systems-thinking approach, proactively identify opportunities and risks, and ensuring our products deliver a seamless user experience while supporting the future needs of a connected healthcare environment. The ideal candidate combines deep technical expertise with exceptional leadership, influencing stakeholders across functions, geographies, and organizational levels to bring complex systems and product visions to life. https://www.stryker.com/us/en/nse.html **What You Will Do** * Lead system architecture, technical strategy, and integration activities for complex medical device products and platforms.* Translate customer, clinical, and business needs into system-level requirements and drive alignment across software, electrical, and mechanical engineering teams.* Lead requirements development, allocation, traceability, and verification planning throughout the product lifecycle.* Drive system-level decision making, architecture reviews, tradeoff analyses, and risk assessments.* Lead cross-functional product development efforts from concept through verification, ensuring delivery of safe, reliable, and high-quality solutions.* Partner with Quality, Regulatory, Clinical, and Engineering stakeholders to ensure compliance with design controls and applicable standards.* Identify, assess, and mitigate product development risks while promoting a risk-based development approach.* Evaluate emerging technologies and recommend new capabilities, platforms, and solutions that support future customer needs.* Build alignment across global stakeholders and influence design direction without direct authority. **What You Will Need (Required Qualifications)** * Bachelor’s degree in Systems, Electrical, Mechanical, Software, Biomedical Engineering, or a related engineering discipline.* 8+ years of relevant engineering experience in product development, systems engineering, or technical leadership roles.* Experience developing products within a regulated industry environment. **Preferred Qualifications** * Medical device product development experience.* Experience leading system architecture and integration activities for complex, multidisciplinary products.* Knowledge of requirements management, verification, and system-level risk management.* Experience with ISO 13485, ISO 14971, FDA Design Controls, or similar regulatory frameworks.* Experience with requirements management tools such as Jama, DOORS, or Polarion.* Experience with Model-Based Systems Engineering (MBSE) and SysML.* Experience developing connected products, digital health solutions, or integrated healthcare technologies.* Experience mentoring engineers and leading design efforts across cross-functional teams. $118,000 - $196,700 USD AnnualTravel Percentage: 20%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.