✦ Luna Orbit — Software Engineering

Principal Digital Systems Engineer

at Stryker

📍 Cary, Illinois Hybrid Posted March 13, 2026
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Position Details

Type Full-Time
Experience senior
Exp. Years 8+ years
Education Bachelor's in Software, Electrical, Mechanical, Systems, or Biomedical Engineering
Category Software Engineering

About this role

This role involves leading complex medical device system design, ensuring regulatory compliance, and guiding cross-functional teams in healthcare technology development.

Key Responsibilities

  • Lead system design and integration
  • Translate user needs into requirements
  • Ensure compliance with standards
  • Mentor engineering teams
  • Drive system verification activities

Technical Overview

Focus on digital system architecture, requirements management, verification, and regulatory standards for medical devices, with expertise in SysML, ISO standards, and cybersecurity.

Ideal Candidate

The ideal candidate is a senior systems engineer with at least 8 years of experience in digital medical device systems, regulatory standards, and requirements management. They possess strong leadership and collaboration skills, with expertise in ISO standards and cybersecurity principles for medical devices.

Must-Have Skills

Bachelor's degree in SoftwareElectricalMechanicalSystemsor Biomedical EngineeringMinimum 8 years of relevant engineering experienceProven expertise in digital system architecturerequirements decompositionand verificationExperience applying regulatory standards such as ISO 13485 and ISO 14971

Nice-to-Have Skills

Proficiency with Requirements Management Software (e.g.Jama)Experience with SysML and Model-Based Systems Engineering (MBSE)Familiarity with medical device cybersecurity principles and practices

Tools & Platforms

JamaISO standardsIEC standards

Required Skills

Requirements Management SoftwareJamaSysMLModel-Based Systems EngineeringISO 13485ISO 14971IEC 60601-1IEC 62304medical device cybersecurityrequirements decompositionverification

Hard Skills

Requirements Management SoftwareJamaSysMLModel-Based Systems EngineeringISO 13485ISO 14971ULCEIEC 60601-1IEC 62304Medical device cybersecurityRegulatory standards

Soft Skills

communicationleadershipcollaborationmentoringproblem-solving

Industry & Role

Industry Healthcare IT
Job Function Lead the design, development, and verification of complex medical device systems.

Keywords for Your Resume

Principal Systems Engineerdigital system architecturerequirements decompositionverificationISO 13485ISO 14971IEC 60601-1IEC 62304medical device cybersecurityrequirements managementSysMLModel-Based Systems Engineeringregulatory standardscollaborationmentoringleadershipRequirements Management SoftwareJamaMedical device cybersecurity

Deal Breakers

Lack of experience with ISO 13485 or ISO 14971, No background in medical device cybersecurity, No prior experience in systems engineering for healthcare

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