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Sr Risk Management Engineer - Pain Therapies

MinneapolisMedtronic



Senior Risk Management Engineer - RTG Pain Therapies

Careers that Change Lives

Provide key technical expertise for establishing the safety of Neuromodulation Pain Therapies medical products/systems that exceed the requirements and expectations of patients, clinicians, regulators and the business.
This position spans the full range of the product life cycle including research, technology, development, market release, and post-market monitoring of new and derivative products.

In this role, you are accountable to ensure that safety is proactively designed into Neuromodulation's products/systems and to predict product/system performance against survivability expectations.
To enable this, you will translate goals into strategies that drive design decisions, assess the design and establish risk requirements, and ensure that any residual risk is within acceptable limits.
You will also responsible for the execution of these strategies.

Come for a job, stay for a career.

A Day in the Life / Responsibilities:

  • Analyze designs to:
    • Identify hazards inherent to design
    • Determine probability of harm due to hazards
    • Evaluate impact to patient safety
    • Quantify residual risk
    • Perform risk/benefit analysis
    • Maintain risk management file for product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation
    • Actively communicate findings to Quality, Development, and Operations teams
  • Understand therapy (clinical) performance, product function(s), and product use environments to appropriately and strategically apply technical knowledge, risk management tools and methodologies to drive safety improvements.
  • Perform systematic risk analysis against features, requirements, architecture, interfaces, and designs, through the appropriate application of risk management techniques (e.g. hazard analysis, risk/benefit analysis) to understand product and process robustness.
  • Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings.
  • Work on organizational process improvement projects, cross-functional business improvement teams, and develop shared best practices to drive functional excellence.
  • May provide guidance, coaching, and training to other employees within job area.


Medtronic RTG (Restorative Therapies Group) Overview

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.

  • PAIN THERAPIES offers solutions - from early interventional procedures to implantable surgical technologies - that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.
  • SPINE THERAPIES shapes spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.
  • BRAIN THERAPIES offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improvethe precision and workflow of neuro procedures.
  • SPECIALTY THERAPIES offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.


Must Have: Minimum Required Qualifications
  • Bachelor's in engineering, science or related technical field
  • 4+ years of engineering experience
  • 1+ years of experience in highly regulated industry (medical device, aerospace, or defense)


Preferred experience:
  • Experience with ISO 14971
  • Master's in engineering, science or related technical field
  • 2+ years Safety or Systems Engineering experience
  • 2+ years of Risk Management
  • Experience in medical devices or other highly regulated industry
  • Experience working in or with Design, Quality and Operations
  • Understand therapy (clinical) performance, product function(s), and product use environments to appropriately and strategically apply technical knowledge, analysis tools and methodologies and to understand and quantify residual risks
  • Proficient in word processing, spreadsheets, and managing electronic data files


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.
  • 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.


RTG (Restorative Therapies Group) Overview

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.
  • PAIN THERAPIES offers solutions - from early interventional procedures to implantable surgical technologies - that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.
  • SPECIALTY THERAPIES, including Medtronic's Pelvic Health Business, offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.
  • SPINE THERAPIES shapes spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.
  • BRAIN THERAPIES offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improvethe precision and workflow of neuro procedures.


ABOUT MEDTRONIC:

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.

EEO STATEMENT:

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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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