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Sr Reliability Engineer (Sr Software Safety Engineer)
8200 Coral Sea Street Northeast Mounds View, MN 55112 US
Job Description
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.
- Leverages relevant field experience and/or clinical knowledge 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 software medical products.
- Completes risk analysis studies of new design and processes.
- Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
- Ensures that corrective measures meet acceptable reliability standards.
- Analyzes preliminary plans and develops reliability/safety engineering programs to achieve company, customer and governmental agency reliability/safety objectives.
- Develops, coordinates and conducts 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.
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:
- Medical doctor with related device experience
- Engineer who has achieved IBHRE or NASPE Exam certification
- Personnel with at least 5 years of clinical field experience in the past 15 years. The relevant field experience could include the following:
- Nurse
- Field Personnel such as: Clinical Specialist, Technical Field Educator, Field
- Clinical Engineer
- Technical Services (cardiac products)
Nice to Have
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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