Product Development Quality Assurance Manager - Rockefeller Neuroscience Institute

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

About the WVU Rockefeller Neuroscience Institute

The WVU Rockefeller Neuroscience Institute (RNI) is a comprehensive multidisciplinary patient care, education, research, and innovation institute providing neurological and mental healthcare for 330,000 patients annually. More than 300 physicians and scientists of the RNI improve lives by pioneering advances in neuroscience, brain health, and therapeutics. The RNI team uses the latest technologies with academic, government, and industry partners to make tangible progress to combat public health challenges ranging from addiction to Alzheimer's disease. For more information visit WVUMedicine.org/RNI.

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.

'',''!*!

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

About the WVU Rockefeller Neuroscience Institute

The WVU Rockefeller Neuroscience Institute (RNI) is a comprehensive multidisciplinary patient care, education, research, and innovation institute providing neurological and mental healthcare for 330,000 patients annually. More than 300 physicians and scientists of the RNI improve lives by pioneering advances in neuroscience, brain health, and therapeutics. The RNI team uses the latest technologies with academic, government, and industry partners to make tangible progress to combat public health challenges ranging from addiction to Alzheimer's disease. For more information visit WVUMedicine.org/RNI.

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.

'',''!*!

• 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.

'',''!*!

• 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.

'','''','''',''!*!

West Virginia University is a place of purpose and community. We take pride in our profound impact on the state of West Virginia and are committed to the personal and professional growth of our employees.

From the groundbreaking R1 research at our flagship campus in Morgantown to the career-oriented programs at WVU Potomac State in Keyser, and the technology-intensive programs at WVU Tech in Beckley, the contributions of WVU employees resonate across the state, touching lives and shaping futures.

At WVU, you will discover a supportive community that champions work-life balance and fosters a collaborative atmosphere. Our core values - service, curiosity, respect, accountability and appreciation - unite us as Mountaineers.

Join us at West Virginia University, where your work will make a lasting impact. To learn more about WVU, visit wvu.edu.

West Virginia University is an Equal Opportunity Employer. We invite all qualified applicants regardless of race, color, religion, sex, national origin, age, disability, genetic information, or Veteran status.

'',''!*!

West Virginia University is a place of purpose and community. We take pride in our profound impact on the state of West Virginia and are committed to the personal and professional growth of our employees.

From the groundbreaking R1 research at our flagship campus in Morgantown to the career-oriented programs at WVU Potomac State in Keyser, and the technology-intensive programs at WVU Tech in Beckley, the contributions of WVU employees resonate across the state, touching lives and shaping futures.

At WVU, you will discover a supportive community that champions work-life balance and fosters a collaborative atmosphere. Our core values - service, curiosity, respect, accountability and appreciation - unite us as Mountaineers.

Join us at West Virginia University, where your work will make a lasting impact. To learn more about WVU, visit wvu.edu.

West Virginia University is an Equal Opportunity Employer. We invite all qualified applicants regardless of race, color, religion, sex, national origin, age, disability, genetic information, or Veteran status.

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