below marketmost similar roles pay hereabove market
This role pays less than
75%
of similar roles. Most pay
$151,868–$214,250
— the blue band above.
At the midpoint, this role pays about
$151k
versus about
$183k
for comparable roles.
Based on 240 similar postings.
Employer
About Medtronic
Medtronic plc is the world's largest medical technology company by revenue, specializing in device-based therapies for over 70 health conditions.
Medtronic currently has
31 open roles
on FindRole.
Listed pay typically runs
$131,200–$196,800
across 31 roles with salary data.
The Sr. Software Systems Engineer - Premarket Design Quality joins the Neuromodulation and Pelvic Health Premarket Design Quality team to support new product development for software-intensive medical device systems. This role involves providing quality oversight and technical guidance throughout the design control lifecycle, ensuring compliance with regulatory requirements. Key responsibilities include reviewing system requirements, architecture, and design documentation, as well as developing verification and validation strategies. The engineer will lead software-related risk evaluations, perform hazard analysis, and conduct root cause analysis for quality issues. Required skills include experience with design controls, software development lifecycle activities, and risk management principles. The role requires knowledge of standards such as IEC 62304, ISO 14971, and ISO 13485 to ensure the safety and efficacy of complex neurological and spinal medical technologies.
Provide design quality support for software-enabled medical device development from concept through manufacturing.
Ensure compliance with design control, software lifecycle, and risk management requirements.
Review and contribute to system requirements, software requirements, architecture, and design documentation.
Develop verification and validation strategies for software, system, and integration testing.
Lead software-related risk evaluation and mitigation verification including hazard analysis.
Evaluate software development deliverables for completeness, traceability, and regulatory readiness.
Perform root cause analysis and corrective action for design or software quality issues.
Mentor junior engineers on design quality practices and compliance requirements.
What we're looking for
Candidates must possess unrestricted U.S. work authorization.
A Bachelor's degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field with 4 years of experience is required.
A Master's degree with 2 years of relevant experience is required.
A PhD with 0 years of relevant experience is required.
Candidates must have demonstrated experience with design controls, software development lifecycle activities, and verification/validation.
Strong understanding of risk management principles, design failure analysis concepts, and traceability across requirements, design, and testing is required.
Experience in software engineering, systems engineering, design assurance, reliability, or quality engineering in a regulated industry (preferred).
Knowledge of IEC 62304, ISO 14971, ISO 13485, FDA design control expectations, and related standards (preferred).
C++
Python
RTOS
Firmware
Machine Learning
Sensor Fusion
Robotics
Embedded Systems
Device Drivers
LiDAR
Control Systems
System Integration
Perception Algorithms