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Sr Post Market Software Reliability Engineer (Mounds View, MN or Remote within the US)

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Engineering
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21000HS6 Requisition #

Senior Post Market Software Reliability Engineer 
21000HS6 
Mounds View, Minnesota or Remote within the US 

Careers That Change Lives  

In this exciting role as a Senior Post Market Software Reliability Engineer you will have responsibility for ensuring the safety and performance of fielded Medtronic Cardiovascular Diagnostics and Services (CDS) and Patient Management (PM) software. You will provide key technical expertise and leadership to monitor and maintain ongoing reliability of software products, like device programmers, clinician information systems, and patient remote monitors. 

Cardiovascular Diagnostics & Services (CDS)

The Cardiovascular Diagnostics & Services (CDS) Operating Unit (OU) is driving a new era of personalized medicine by empowering care providers and patients with actionable insights to conquer chronic disease.

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. 

A Day in the Life 

Responsibilities may include the following and other duties may be assigned. 

  • Monitors performance of fielded software products to identify trends and issues. 
  • Escalates issues, performs risk assessments, and assists in the management of issues to resolution. 
  • Develops and maintains post-market vigilance deliverables in accordance with procedures. 
  • Participates in cross-functional teams in the preparation of risk management documentation, including product impact assessments, Hazard Analyses, Post Market Surveillance Reports, etc.  
  • May fulfill the role of “Personnel with Clinical Knowledge” in risk management assessments if specialized experience criteria are met 
  • Represents quality on development teams implementing software changes to issues identified in post-market. 
  • Partners with the CDS and PM businesses to analyze reliability trends in relation to new product development. 
  • Participates in and leads organizational efforts to improve quality processes, outcomes, and culture. 
  • Develops ideas and concepts for improved performance monitoring and partners with development teams to see them implemented. 
  • Providing input for regulatory submissions. 
  • Develops, coordinates, and conducts technical reliability 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. 
  • 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 engineering programs to achieve company, customer and governmental agency reliability objectives. 
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability. 
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data. 
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume. 

Bachelors degree in engineering, science or technical field with 4+ years of experience in quality and/or engineering OR Advanced degree in engineering, science or technical field with 2+ years of experience in quality and/or engineering.


Nice to Have

  • Software engineering, computer science, or related degree 
  • Experience in software development or software reliability, and experience working in a regulated environment. 
  • Demonstrated ability to perform data analysis using statistical techniques and reliability tools. 
  • Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact 
  • Excellent problem solving skills, including demonstrated application of structured problem solving methods and tools 
  • Sufficient reliability engineering and statistics knowledge 
  • Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) 
  • Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others’ needs, negotiate for win-win, own the whole) 

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Less than 10% Travel

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