WVU Medicine

Product Development Quality Assurance Manager - Rockefeller Neuroscience Institute

WVU Medicine • $80K — $110K *
Morgantown, WV 26505In-Person
Healthcare
Less than 5 years of experience
3 weeks ago
Job Overview by Ladders

Qualifications

  • Master's degree in a relevant field required
  • Minimum of two years of related experience
  • Equivalent education or experience combination considered
  • Completion of qualifications necessary by employment start date
  • Expertise in FDA design controls such as ISO 14971 and ISO 62304

Responsibilities

  • Collaborate with engineers and team members on ultrasound product development
  • Participate in IRB submission processes
  • Support design controls for product development
  • Contribute to design documentation
  • Engage in hands-on quality assurance practices

Benefits

  • 37.5-hour work week
  • 13 paid holidays annually
  • 24 annual leave days
  • 18 sick days per year for personal or family health needs
  • Range of health insurance options
  • 401(a) retirement savings with 6% employee contribution match
  • Access to wellness programs
Full Job Description
Description

The Rockefeller Neuroscience Institute of West Virginia University is accepting applications for a Product Development Quality Assurance Manager.

About the Opportunity

The WVU Rockefeller Neuroscience Institute is developing state-of-the-art focused ultrasound neuromodulation technologies and products. We are seeking a hands-on Quality Assurance Manager to support design controls for the development of ultrasound products for submission to IRBs and the FDA suitable for human clinical use. This is a hybrid position with the expectation of being on-site at the RNI in Morgantown, WV approximately once per month.

We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including:

  • 37.5-hour work week
  • 13 paid holidays (staff holiday calendar)
  • 24 annual leave (vacation) days per year (employee leave)
  • 18 sick days per year (for when you're ill, for when you need time to care for sick family, for your own, or your family's, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
  • WVU offers a range of health insurance and other benefits
  • 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information? Check out retirement health insurance benefits, retirement income, and FAQ's.
  • Wellness programs


What You'll Do

  • Collaborate with other engineers and team members on the development of ultrasound products.
  • Participate in IRB submission.
  • Support the design controls for products.
  • Participate in design documentation.


Qualifications

  • Master's degree in relevant field required
  • At least two (2) years of relevant experience required
  • Any equivalent combination of related education and/or experience will be considered.
  • All qualifications must be met by the time of employment.


Knowledge, Skills and Abilities

  • Expertise in the use of ultrasound lab equipment including oscilloscopes, function generators, amplifiers, ultrasound transducers, and hydrophones.
  • Interfaces with PCs. Preferably familiar with LabView, MatLab, K-wave, 3-D Slicer, Schlieren imaging, SolidWorks and similar.
  • Ability to do basic fixture and other mechanical design a plus.
  • Comfortable using Microsoft office suite.
  • Expert in FDA design controls including 14971, 62304, design history files, and conducting design reviews.
  • Resourceful, hands-on and self-motivated.
  • Excellent communications skills.
  • Detail oriented. Documentation in support of product development and regulatory submissions.
  • Excellent team player. Able to collaborate well with engineers and other team members.


Preferred Qualifications

  • Proven medical device quality management experience in an industry setting preferred.

About WVU Medicine

West Virginia University Health System is a non-profit organization that offers a full range of healthcare services.

WVU Medicine Careers

There has never been a better time to explore the diverse job opportunities at WVU Medicine, the premier destination for top-tier healthcare professionals. As the largest healthcare provider in West Virginia, WVU Medicine is at the forefront of medical innovation and patient care.

Work You’ll Do

Join WVU Medicine’s esteemed team to assist in transforming healthcare across the region. This is an opportunity to be part of a culture that values growth, leadership, and professional development. Engage in meaningful work that makes a difference, leveraging the latest in medical technology and practices. WVU Medicine positions itself uniquely at the nexus of patient care, research, and education, making it a pivotal platform for career advancement in the healthcare industry.

WVU Medicine Job Opportunities

The team is actively building a robust employment infrastructure to support some of the most well-known communities in healthcare. WVU Medicine offers a variety of positions, from clinical roles to administrative support, ensuring a fit for a wide range of skills and interests.

Innovate and Lead

At WVU Medicine, innovation isn’t just a buzzword—it's a practical part of daily operations. The company is home to a dynamic team of over 20,000 dedicated professionals who bring groundbreaking medical treatments and technologies to life.

Cultivate Your Career

WVU Medicine is committed to fostering a workplace where every team member can thrive. Employees enjoy comprehensive benefits, diversity training, and numerous channels for professional growth through leadership development programs and internships.

Explore WVU Medicine

From implementing advanced electronic medical records to enhancing patient care protocols, WVU Medicine is a leader in healthcare innovation. The company’s commitment to excellence is evident in its proactive approach to healthcare challenges and its continuous pursuit of improvement.

The WVU Medicine Experience

WVU Medicine’s collaborative environment is ideal for those who are driven to excel in their careers and make a significant impact in healthcare. The company’s emphasis on teamwork and networking creates a strong foundation for personal and professional development.

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Learn more about WVU Medicine
Size
10,001 employees
Industry
Hospitals & Medical Centers
* Ladders Estimates

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