This role pays less than
78%
of similar roles. Most pay
$154,375–$211,450
— the shaded 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
66 open roles
on FindRole.
Listed pay typically runs
$124,000–$184,800
across 65 roles with salary data.
Sr. Software Systems Engineer - Premarket Design Quality
The Sr. Software Systems Engineer on the Neuromodulation and Pelvic Health Premarket Design Quality team provides critical oversight for software-intensive medical device systems throughout the design control lifecycle. This role involves partnering with cross-functional teams to ensure that system-level design activities are planned, executed, and documented in compliance with regulatory requirements. Key responsibilities include reviewing system and software requirements, developing verification and validation strategies, performing hazard analysis, and conducting root cause analysis for quality issues. The ideal candidate possesses expertise in risk management, traceability, and the software development lifecycle. Required skills include knowledge of IEC 62304, ISO 14971, and ISO 13485 standards. This role solves complex technical challenges by ensuring that medical device software meets rigorous safety and regulatory standards before reaching the manufacturing phase.
Provide design quality support for software and medical device programs from concept through manufacturing.
Ensure compliance with design control, software lifecycle, and risk management requirements.
Review and contribute to system requirements, software architecture, and design documentation.
Develop verification and validation strategies for software, system, and integration testing.
Evaluate software deliverables for completeness, traceability, and regulatory readiness.
Perform risk management activities including hazard analysis and mitigation verification.
Participate in design reviews to provide feedback on product safety and compliance.
Mentor junior engineers on design quality practices and documentation requirements.
What we're looking for
Bachelor's degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field with 4 years of experience.
Master's degree in a related technical field with at least 2 years of relevant experience.
PhD in a related technical field is acceptable with no minimum years of experience required.
Demonstrated experience with design controls, software development lifecycle activities, and verification/validation.
Strong understanding of risk management principles, design failure analysis, and requirement traceability.
Experience supporting cross-functional product development teams.
Experience in the medical device industry or other highly regulated environments (preferred).
Work authorization at the time of hire and for the duration of employment.
SDLC
Verification and Validation
Python
C++
MATLAB
Artificial Intelligence
Machine Learning
IEC 62304
ISO 13485
ISO 14971
SaMD
Test Automation
Risk Management
Design Controls
ISO 13485
21 CFR Part 820
ISO 14971
ANSI HE75
FMEA
CAPA
Design Control
Risk Management
Human Factors Engineering
Statistical Process Control
DOE
Root Cause Analysis
Validation
Verification