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Sr Design Quality Engineer (Medical Device)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Sep 9, 2022

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Discipline
Engineering, Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work
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Job Details

We are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles.

In this role, a typical day might include the following:

  • Reviewing design and development paperwork and records for compliance to internal procedures and regulations

  • Ensuring accurate justification of statistical analysis and hypothesis testing

  • Reviewing technical reports as well as documents for Design History Files

  • Participating in device risk management activities including UFMEA, DFMEA, PFMEA

  • Aiding in establishing statistical controls in development and transfer to manufacturing processes

  • Verifying data integrity, electronic data storage and data sheet validations

  • Reviewing and coordinating with QA Validation for all test method and design validations

  • Reviewing activities related to Design Verification and Design Transfer of Medical Devices

  • Ensuring work product meets regulations

  • Supporting scientific, complaint, and test failure investigations

  • Performing data trend analysis, participating in Phase Reviews, writing Quality Procedures, performing data/statistical analysis

This role might be for you if:

  • You have knowledge of the combination device development process

  • You have experience with device risk management activities

  • You have a quality mind-set

To be considered for this role you must hold a Bachelor’s degree in an Engineering subject area and the following amount of work experience in combination device or medical device industry for each level:

  • Quality Engineer: 2+ years

  • Senior Quality Engineer: 5+ years

  • Principal Quality Engineer: 8+ years

Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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