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Software safety engineer ii

Galway
Medtronic
Safety engineer
Posted: 23h ago
Offer description

At Medtronic you can begin a life‑long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life

Identify, analyse, and mitigate patient safety hazards in Medtronic software in collaboration with cross‑functional teams
Conduct comprehensive risk analyses for new designs and processes, including severity and occurrence assessments and risk‑benefit evaluations for cardiac medical products
Develop and maintain risk management files in compliance with ISO 13485, ISO 14971, and IEC 62304, ensuring alignment with design inputs and outputs
Lead traceability of design verification and validation within risk management documentation to ensure all safety measures meet global regulatory standards
Support and execute reliability and safety engineering studies, including design of experiments (DOE), to evaluate design concepts and system performance
Develop and implement reliability and safety engineering programs to meet company, customer, and regulatory requirements
Recommend and implement design improvements, test methods, and statistical process control techniques to enhance product reliability and safety
Ensure corrective and preventive actions meet established safety and reliability standards
Provide data‑driven risk‑benefit insights and propose innovative risk mitigation strategies to stakeholders, prioritizing patient safety
Design and develop reusable patterns and encourage innovation that will increase team velocity

Key Skills & Experience

Bachelor’s degree in engineering, math, science or technical discipline and minimum of 2 years of work experience in engineering and/or quality OR advanced degree in engineering, science or technical field with 2+ years of work experience in engineering and/or quality
Proven understanding of product reliability/safety engineering principles
Experience in a highly regulated industry, preferably implantable medical devices
Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HAL, FTA, DFMEA)
Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms
Experience in design, maintenance, or continuation engineering of released software or software systems, including mobile applications
Working knowledge of artificial intelligence (AI) tools and Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices
Experience with Agile methodologies and proficiency in two or more of the following technologies: C++, Java, JavaScript, HTML, C#, .NET, Python, Angular, Xamarin

Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. Pay range / Rango salarial / Intervalo salarial / Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 49,920.00 EUR - 74,880.00 EUR
This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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