8200 Coral Sea Street Northeast Mounds View, MN 55112 US
Posted: 11/03/2025 2025-11-03 2025-12-04 Employment Type: Contract Job Category: Engineering Job Number: 623619 Is job remote?: No Country: United States
In this exciting role as a Sr. Software Safety Engineer 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 Sr. Software Safety Engineer will drive excellence in quality and reliability programs. This dynamic role involves leading Design for Reliability (DfR) initiatives, offering technical expertise, 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
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s degree in engineering, science or technical field with 4+ 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.
Qualified to assess patient safety risks via one of the following:
Personnel with at least 5 years of previous clinical experience related to cardiac therapy products.
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, including experience with Minitab.
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).
Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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