Product Development Quality Assurance Manager - Rockefeller Neuroscience Institute

West Virginia University • West Virginia, WV

2d • Hybrid

About The Position

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.

Requirements

• 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.
• Expertise in the use of ultrasound lab equipment including oscilloscopes, function generators, amplifiers, ultrasound transducers, and hydrophones.
• Interfaces with PCs.
• 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.

Nice To Haves

• Preferably familiar with LabView, MatLab, K-wave, 3-D Slicer, Schlieren imaging, SolidWorks and similar.
• Proven medical device quality management experience in an industry setting preferred.

Responsibilities

• 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.

Benefits

• 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%25 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 This Job Offers

• Job Type: Full-time
• Career Level: Manager