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Senior Engineering Manager

Experience Level:  Manager
Job Type:  Full-Time
Location: 

MN - Plymouth, US

Requisition ID:  1317

General Summary:

Qorvo (Nasdaq: QRVO) is All Around You! We make a better world possible by providing innovative Radio Frequency (RF) solutions at the center of connectivity. We combine product and technology leadership, systems-level expertise and global manufacturing scale to quickly solve our customers’ most complex technical challenges. 

Leveraging Qorvo’s innovative RF solutions, Qorvo Biotechnologies has developed a differentiated in-vitro diagnostic platform that delivers high sensitivity and accuracy to clinical laboratories and point of care settings.  With the recent award from NIH, it is rapidly ramping up business infrastructure and market launch to address $10BN immunoassay and molecular testing market opportunities.  It provides dynamic career growth opportunities within very engaged and inspired team environment.

 

Summary:

Qorvo Biotech is looking for a Sr. Engineer Manager who will play an integral role in our R&D team.  This position leads the systems engineering team responsible for the development of in vitro diagnostic (IVD) products based on Qorvo’s industry-leading point of care system . The person in this role will oversee the IVD engineering activities on multiple projects to commercialize existing and new products in all of the worldwide markets. This leader will mentor and grow the IVD engineering function by setting best practices, educating the department on global regulatory requirements, and expanding the capabilities of team. This role requires a broad grasp of multiple areas of engineering electrical, RF, Bulk Acoustic wave sensors immuno assays, thermal, microfluidic systems, electro-mechanical systems, instrument control software/firmware and data infomatics .

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Description of Essential Duties:

  • Systems engineering activities on IVD product development projects, including development of product design user needs, requirements specifications, traceability, risk management (FMEAs, Hazard Analysis, etc), verification and validation
  • Refine  IVD product development strategy considering all commercial and operational implications. Navigate the different requirements of RUO, EUA and 510k products, and optimize for the most efficient path to be successful in all markets
  • Hands on member on product development teams to ensure completeness of the design history file. Support regulatory submissions, including creation, review, and management of technical documents
  • Execution of engineering deliverables associated with development of IVD products, with a focus on instrumentation, software and data transport
  • Functional management of the electrical, mechanical, sensor and software teams ensuring both technical depth functional excellence.
  • Manage resource allocation effectively across multiple sites and programs.
  • Refine and create engineering process within Qorvo Biotech and Qorvo corp.
  • Suppport configuration control with Qorvo Biotech and all manufacturing sites
  • Foster strong relationships with Assay R&D, Operations, and QA/Regulatory teams to ensure seamless transfer of new products into manufacturing and the field

 

Qualifications

• M.S./Ph.D. in Electrical Engineering minimum of 15 years relevant industry experience

• Proven experience in developing and launching medical/IVD products to the regulated market

• Demonstrated success in building and growing strong and technically deep engineering teams

• Demonstrated experience in characterization and testing of complex instrumentation systems

• Solid knowledge of regulatory standards such as ISO13485, ISO 14971, FDA QSR 21 CFR 820, 21 CFR Part 11 and AAMI standards applicable to medical devices

• Specific experience in development point of care diagnostic analyzers, microfuildics, microwave instrumentation and biochemistry is a benefit.

 

Physical Requirements: Constant hearing, talking and near vision. Frequent sitting (80%) and standing (moving about) (20%). Occasional handling, reaching. Occasionally lifts and carries up to 35 pounds.

 

Mental/Motor Requirements: Constant reading, writing, tact, problem solving, verbal communication and independent decision-making. Frequent written communication.

 

Environmental Requirements: Frequently works with others in office and manufacturing environment.

 

Other: Ability to organize and prioritize multiple projects. Ability to reprioritize project duties and tasks based on department and business need. Excellent communication skills with strong troubleshooting and problem-solving abilities.

 

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MAKE A DIFFERENCE AT QORVO   

 

We are Qorvo. We do more than create innovative RF solutions for the mobile, defense and infrastructure markets – we are a place to innovate and shape the future of wireless communications. It starts with our employees. As a unified global team, we bring a commitment to excellence, growth and a passion for creating what's next. Explore the possibilities with us.

 

We are an Equal Employment Opportunity (EEO) / Affirmative Action employer and welcome all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, military or veteran status, physical or mental disability, genetic information, and/or any other status protected by law.

 

Qorvo is an E-Verify Employer. For more information, please see the Right to Work and E-Verify Participation posters.


Nearest Major Market: Minneapolis

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