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Senior Software Risk and Reliability Engineer

Medtronic


Location:
Fridley, MN 55432
Date:
03-12-2020
2020-12-032021-02-08
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Job Details

Senior Software Risk and Reliability Engineer

Location:

Fridley, Minnesota, United States

Requisition #:

20000I98

Post Date:

Nov 30, 2020


**Careers That Change Lives**


This position as a **Post Market Senior Software Risk and ReliabilityEngineer** will provide software and
hardware risk management support to post market activities within the Medtronic
Neuromodulation Quality organization.
This includes evaluating software anomalies and product non-conformances
to ensure risks and potential risks are identified, evaluated and if applicable
escalated for product actions. This role
may also be expected to flex into the pre-market space, with responsibility for
product reliability and safety to ensure the product/system performance is
quantifiably predicted.


The **Restorative Therapies Group** develops
life-restoring therapies and healthcare solutions that span the care continuum;
integrating technologies and applying clinical and economic evidence to
increase patient access, improve efficiency of procedures and deliver
successful patient outcomes.


**Neuromodulation** delivers innovative therapies and solutions for neurological diseases,
pain, and spasticity.


**A Dayin the Life**


Responsibilities specific to the Post Market
Senior Software Risk and Reliability Engineer:


+ Collaboratewith different departments across the organization to understand andreview data to assess the patient/user risk associated with the postmarket life-cycle phase.

+ Assessrisks that were not previously identified, as well as potential risksassociated with changes in therapy, systems, products, components,manufacturing processes,

+ ProvidePost-Market reliability support for embedded firmware products, healthsoftware products as well as distribution of health care softwareproducts.

+ Collaboratewith Medical Safety to review and analyze field data, discuss the harmseverity sources and estimate the probability or harm occurrence.

+ Author system andproduct level risk documentation with traceability for risk management files describingstatus of risk controls/mitigations.

+ Determineif risk management files need to be reviewed and updated.

+ Participatein the identification, assessment and disposition of software anomalies.

+ Representthe organization as a technical contact for risk and reliability forprocesses such as: Non conformances, Anomaly Dispositions, Deviations, ComplaintFormal Investigations, Change Control and CAPA among others.

+ Asnecessary, participate in Software Hazard Assessment (SHA) for therapydevices, clinician and patient programmers, and product instruments.

+ Mayperform benefit-risk analysis for medical product and/or system.

+ Providedesign input to new product development for health care software andembedded software systems.

+ Develops,coordinates and conducts technical reliability studies and evaluations ofengineering design concepts and design of experiments (DOE) constructs.

+ Recommendsdesign or test methods and statistical process control procedures forachieving required levels of product reliability.

+ Completesrisk analysis studies of new design and processes.

+ Compilesand analyzes performance reports and process control statistics;investigates and analyzes relevant variables potentially affecting productand processes.

+ Ensuresthat corrective measures meet acceptable reliability standards.

+ Analyzespreliminary plans and develops reliability engineering programs to achievecompany, customer and governmental agency reliability objectives.

+ Maydevelop mathematical models to identify units, batches or processes posingexcessive failure risks.

+ Asnecessary, proposes changes in design or formulation to improve systemand/or process reliability.

+ Maydetermine units and/or batches requiring environmental testing, andspecifies 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 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.


**Nice to Have: Preferred Requirements**


+ Bachelors Degree in Software or Computer Engineering or related science.

+ Experience with Software Application or Embedded Software development and testing.

+ Experience in medical devices or other highly regulated industry such as defense or automotive.

+ Experience in quality, reliability, design assurance, safety, or systems engineering.

+ Experience with and knowledge of medical device standards including ISO 13485, ISO 14971 (risk mgmt.), 62304 (medical device SW), and 82304 (health care SW).

+ Strong understanding of industry expectations in the areas such as voice of customer, software development, requirements analysis, risk management, software testing levels, software reliability, software use conditions, software metrics etc.

+ Experience working on projects using Agile SW development

+ Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, validation, and prediction

+ Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.)

+ Design techniques such as use cases, functional analysis, timeline analysis, and sequence diagrams

+ Requirements Management Software such as PTC Integrity, Code Beamer, Jama, DOORs, JIRA, Cockpit

+ Experience in the design, maintenance, or continuation engineering of software or software systems, including mobile applications

+ Knowledge of scripting languages and test automation

+ Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships

+ Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude

+ Ability to lead cross-functional teams and drive discussion and decision-making. This includes facilitation, consensus building and conflict resolution.

+ Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience), including presentation skills

+ High degree of initiative and self-motivation

+ Strong attention to detail and accuracy

+ Excellent organization skills; ability to successfully balance and prioritize multiple ongoing projects/tasks

+ Strong analytical skills and the ability to solve problems through analytical reasoning.

+ Design for Reliability and Manufacturability (DRM) certification

+ ASQ Certification in Quality or Reliability


**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. Lets 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)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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