Job Description

Job Description

Job Description

In this exciting role as a Software Safety Engineer II, you will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.

This position offers an exciting opportunity to drive software reliability and safety engineering within dynamic new product development teams for R&D. The candidate will be a pivotal member of cross-functional teams, serving as the go-to expert for reliability, safety, and quality functions.

As a core member of the R&D project teams, the Software Safety Engineer II will drive excellence in quality and reliability programs. This dynamic role involves supporting Design for Reliability (DfR) initiatives, actively participating in design and risk reviews, and shaping the development of cutting-edge technologies. Collaborating with multidisciplinary teams, the position is pivotal in ensuring that innovative solutions meet the highest safety and reliability standards, fostering impactful advancements in patient care.

This position is in Mounds View, MN. within the Cardiac Rhythm Management (CRM) Operating Unit and requires on-site presence three days a week.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life

In general, the following responsibilities apply for the Software Safety Engineer II role. This includes, but is not limited to the following:

• Leverage relevant medical technology experience to ensure the practical applicability and safety of our products in real-world settings.
• Completes risk severity and occurrence determination and analyze risk benefit profiles for cardiac medical products.
• Completes risk analysis studies of new design and processes. 
• Ensures that corrective measures meet acceptable reliability/safety standards. 
• Analyzes preliminary plans and supports development of reliability/safety engineering programs to achieve company, customer and governmental agency reliability/safety objectives. 
• Support technical reliability/safety studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. 
• Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability and safety. 
• Proposes changes in design or formulation to improve system and/or process reliability and product safety. 

Qualifications –

Must Have - Minimum Requirements

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

Bachelor’s degree with 2 years of work experience in engineering and/or quality

Nice to Have

• Advanced degree in engineering or science.
• Proven understanding of product reliability/safety engineering principles.
• Strong understanding of and experience in the application of statistics.
• Experience in a highly regulated industry, preferably implantable medical devices. 
• Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc. 
• Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA). 
• Certified Software Reliability Engineer (CSRE) certified. 
• Exposure to or experience working in or with design, quality, regulatory, clinical and/or manufacturing. 
• Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications.
• Knowledge of 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.
• Previous clinical field experience, specifically with cardiac rhythm management products.

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

Company Description

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

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