Staff SaMD Quality & Compliance Engineer – Hybrid

Regulatory Jobs

Portage (MI)

Hybrid

USD 118,000 - 197,000

Full time

14 days+

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Stryker is seeking a Staff Software Design Quality Engineer for its Smart Care division, spanning digital, cloud-based, and software-enabled medical solutions. The role blends software development with regulatory compliance and risk management.

The position is hybrid or onsite with multiple US locations. You will drive quality systems, guide lifecycle processes, conduct FMEA and security reviews, and help teams deliver compliant software products at scale.

Qualifications

Bachelor’s degree in Engineering, Sciences, or a related technical discipline.
Minimum 4 years of experience in a regulated industry within R&D, Quality, Software Engineering, IT, Healthcare IT, or Systems Engineering.
Experience with software development lifecycle methodologies (Agile, SAFe, Waterfall).
Experience with software risk management, FMEA, security risk assessments, defect management, verification and validation.

Responsibilities

Lead software quality and compliance activities for cloud-based SaaS and software-enabled medical technologies.
Guide product development teams through lifecycle requirements, quality system processes, and design control documentation.
Conduct risk assessments, FMEA, security risk reviews, and change-impact assessments throughout development and sustaining activities.
Review quality deliverables, design docs, and release readiness for regulatory compliance.
Develop and improve quality procedures, templates, and governance for scalable software development.