Global UNiD Quality, Process, and Training Engineer - Remote, USA

Medtronic

null

United States

Education - Excluding Post Secondary
(No Timezone Provided)

Careers that Change Lives

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

In this exciting role as a Global UNiD Quality, Process, and Training Engineer you will have responsibility for working collaboratively with the Global UNiD management team to 1. develop a systematic training process for the global UNiD lab team, 2. development of deep technical expertise and knowledge of factors affecting spine quality, planning variability, and objective quality, 3. ongoing documentation and updating of standard operating procedures focused on the surgical planning process, 4. R&D projects focused on surgical planning, optimization of workflow, quality, and process redesign. This role is critical as we grow and scales this business across the full cranial and spinal technologies business globally.

Our goal is focused yet complex, to transform spine surgery by putting personalized, actionable data technology in the hands of every surgeon and patient. We provide adaptive surgical planning, patient specific solutions, and data analytics to enable surgeons and patients to make and execute data-driven decisions.

About UNiD

Our systems-based technology platform is built to support surgeon work by harnessing the power of Adaptive Spine Intelligence™. We consult with the surgical team to integrate UNiD™ ASI seamlessly into the surgical planning process.

There are three areas of focus for the UNiD technology: planning services, personalized implants, and predictive modeling

UNiD LAB ™ is our team of biomedical engineers who work collaboratively with surgeons to simulate surgical strategies and technologies using proprietary data and algorithms with detailed outcome reporting.

UNiD ™ TEK is our range of patient-specific implants delivered just-in-time for surgery. Surgeons can focus on the patient with the optimized implant solutions ready before stepping foot into the operating room.

UNiD™ HUB is our software interface. It digests scientific data to generate intelligent surgical planning through machine learning while simultaneously allowing surgeons to perform detailed, custom analyses of their cases and manage the entire workflow from pre-op to post-op phase.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A DAY IN THE LIFE:

  • Manage the continuous improvement program for case measurement and planning, including ongoing standardization initiatives
  • Maintain and expand the advanced training program for consultants, US and OUS Lab
  • Lead the quality monitoring program for case planning deliverables and data
  • Collaborate with senior lab personnel to define quality objectives and definitions of plan success
  • Collaborate with surgeons, subject matter experts (SMEs) and data scientists to integrate new learning and expert opinion into case planning
  • Lead the change management process for supporting the release of new planning parameters and guidance
  • Harmonize the US/French planning and QA processes
  • Lead quality-critical documentation initiatives
  • Collaborate with the HUB development team on R&D initiatives related to measurements, planning, and surgical preferences
  • Manage HUB training for new releases
  • Maintain and update the HUB user guide and collaboration on standard operating procedures
  • Ensure user acceptance testing (UAT) for the HUB is conducted successfully
  • Travel requirement: 25-50%
  • MUST HAVE - MINIMUM REQUIREMENTS:

    TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

  • Bachelors degree required
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
  • NICE TO HAVE:

  • Experience working with complex spinal procedures.
  • Experience with surgeon engagement.
  • Ability to engage in change management processes, communicate changes with team, and influence change management across a broad stakeholder group.
  • UNiD lab or consulting experience
  • Experience with medical device design for reliability tools and modeling.
  • Mechanical Design Experience
  • Certified Quality Engineer (CQE) or other similar Quality/Reliability certifications
  • Lean Six Sigma green/black belt
  • Experience in utilization of statistical techniques such design of experiments, hypothesis testing, SPC, etc. as part of Quality Engineering discipline.
  • Working knowledge of process improvement skills.
  • Strong knowledge in CAPA, NCMR, RMA, Labeling, Rework and Batch release processes.
  • Ability to work effectively in a team environment with a diverse group of people.
  • Ability to effectively solve problems.
  • Strong technical understanding.
  • Fluent in English or French are beneficial as well
  • Experience managing the continuous improvement programs
  • Experience running a training program
  • Experience leading a quality monitoring
  • Experience in the development of standard operating procedures
  • Experience working with outside consultants and cross functional teams

  • 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) Additional Information
  • Posting Date: Nov 8, 2021
  • Travel: Yes, < 50 % of the Time
  • Global UNiD Quality, Process, and Training Engineer - Remote, USA

    Medtronic

    null

    United States

    Education - Excluding Post Secondary

    (No Timezone Provided)

    Careers that Change Lives

    A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

    In this exciting role as a Global UNiD Quality, Process, and Training Engineer you will have responsibility for working collaboratively with the Global UNiD management team to 1. develop a systematic training process for the global UNiD lab team, 2. development of deep technical expertise and knowledge of factors affecting spine quality, planning variability, and objective quality, 3. ongoing documentation and updating of standard operating procedures focused on the surgical planning process, 4. R&D projects focused on surgical planning, optimization of workflow, quality, and process redesign. This role is critical as we grow and scales this business across the full cranial and spinal technologies business globally.

    Our goal is focused yet complex, to transform spine surgery by putting personalized, actionable data technology in the hands of every surgeon and patient. We provide adaptive surgical planning, patient specific solutions, and data analytics to enable surgeons and patients to make and execute data-driven decisions.

    About UNiD

    Our systems-based technology platform is built to support surgeon work by harnessing the power of Adaptive Spine Intelligence™. We consult with the surgical team to integrate UNiD™ ASI seamlessly into the surgical planning process.

    There are three areas of focus for the UNiD technology: planning services, personalized implants, and predictive modeling

    UNiD LAB ™ is our team of biomedical engineers who work collaboratively with surgeons to simulate surgical strategies and technologies using proprietary data and algorithms with detailed outcome reporting.

    UNiD ™ TEK is our range of patient-specific implants delivered just-in-time for surgery. Surgeons can focus on the patient with the optimized implant solutions ready before stepping foot into the operating room.

    UNiD™ HUB is our software interface. It digests scientific data to generate intelligent surgical planning through machine learning while simultaneously allowing surgeons to perform detailed, custom analyses of their cases and manage the entire workflow from pre-op to post-op phase.

    We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

    A DAY IN THE LIFE:

  • Manage the continuous improvement program for case measurement and planning, including ongoing standardization initiatives
  • Maintain and expand the advanced training program for consultants, US and OUS Lab
  • Lead the quality monitoring program for case planning deliverables and data
  • Collaborate with senior lab personnel to define quality objectives and definitions of plan success
  • Collaborate with surgeons, subject matter experts (SMEs) and data scientists to integrate new learning and expert opinion into case planning
  • Lead the change management process for supporting the release of new planning parameters and guidance
  • Harmonize the US/French planning and QA processes
  • Lead quality-critical documentation initiatives
  • Collaborate with the HUB development team on R&D initiatives related to measurements, planning, and surgical preferences
  • Manage HUB training for new releases
  • Maintain and update the HUB user guide and collaboration on standard operating procedures
  • Ensure user acceptance testing (UAT) for the HUB is conducted successfully
  • Travel requirement: 25-50%
  • MUST HAVE - MINIMUM REQUIREMENTS:

    TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

  • Bachelors degree required
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
  • NICE TO HAVE:

  • Experience working with complex spinal procedures.
  • Experience with surgeon engagement.
  • Ability to engage in change management processes, communicate changes with team, and influence change management across a broad stakeholder group.
  • UNiD lab or consulting experience
  • Experience with medical device design for reliability tools and modeling.
  • Mechanical Design Experience
  • Certified Quality Engineer (CQE) or other similar Quality/Reliability certifications
  • Lean Six Sigma green/black belt
  • Experience in utilization of statistical techniques such design of experiments, hypothesis testing, SPC, etc. as part of Quality Engineering discipline.
  • Working knowledge of process improvement skills.
  • Strong knowledge in CAPA, NCMR, RMA, Labeling, Rework and Batch release processes.
  • Ability to work effectively in a team environment with a diverse group of people.
  • Ability to effectively solve problems.
  • Strong technical understanding.
  • Fluent in English or French are beneficial as well
  • Experience managing the continuous improvement programs
  • Experience running a training program
  • Experience leading a quality monitoring
  • Experience in the development of standard operating procedures
  • Experience working with outside consultants and cross functional teams

  • 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) Additional Information
  • Posting Date: Nov 8, 2021
  • Travel: Yes, < 50 % of the Time