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Engineering
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21000B2R Requisition #
Careers That Change Lives
In this exciting role as a Senior Reliability Engineer you will have responsibility for planning and leading product Firmware and Electrical reliability and safety technical assessments and compliance activities to ensure that reliability and safety is proactively designed into our products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted.  Your work will span the product development lifecycle from technology through development and early market release of new and derivative products.
CRM
The Cardiac Rhythm Management operating unit employs the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe, focusing on 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:
  • Plan, lead, execute, and integrate Design for Reliability (DfR), to quantify product reliability.
  • Develop test plans and work with test lab to demonstrate reliability and adherence to standards. May determine units and/or batches requiring environmental testing and specify minimum number of samples to obtain statistically valid data. Write test reports in a format that adequately meets regulatory guidelines.
  • Interact with design partners to understand product design, especially for novel features. Evaluate design for potential failure modes. As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • Complete risk analysis studies of new firmware and/or electrical design and processes. Develop mitigations of risk in conjunction with Design team.
  • Ensure that corrective measures meet acceptable reliability standards.
  • Advocate for Quality in design reviews and other project meetings
  • Responsibilities may include the following and other duties may be assigned.
  • 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.
TECHNICAL SPECIALIST CAREER STREAM:
An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies.  Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.  May act as a mentor to colleagues or may direct the work of other lower level professionals.  The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS:
  • Autonomy
  • Seasoned individual contributor.
  • Works independently under limited supervision to determine and develop approach to solutions.
  • Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area.
  • Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
  • Makes improvements of processes, systems or products to enhance performance of the job area.
  • Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors.
  • Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.
  • May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
  • May have practical knowledge of project management.
Must Have: Minimum Requirements
 
  • Bachelors degree required
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

  • Advanced degree in Electrical Engineering, Computer Engineering, Computer Science; or suitable firmware, software, electrical design, or reliability experience with Biomedical Engineering, Safety Engineering, or Clinical/Field Support experience.
  • Experience in a highly regulated industry, preferably implantable medical devices.
  • Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, EN 45502/ISO 14708, IEC 60601, ISO 14971, hazard analysis and risk analysis techniques (e.g., FTA, DFMEA, Risk Management Report), and/or IBHRE Certified EP Specialist (Allied Professional).
  • Certification (belts) in Design for Reliability and Manufacturability (DRM) or Design for Six Sigma (DFSS). ASQ CRE certified.

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)

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