Medical Device Quality Engineer

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 66,000 - 144,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY seeks a Medical Device Quality Engineer to provide QA support for combination products developed in-house and with partners.

The role emphasizes design reviews and regulatory compliance necessary for medical devices and biologics-related products. Responsibilities include risk management, design verification and transfer, test method development, and investigations.

Qualifications

• Bachelor's degree in engineering is required.
• Experience working in either combination products or medical devices is required.
• Senior Engineer requires 5 years of experience.

Responsibilities

• Reviews and supports Design and Development documentation for compliance to internal procedures and regulations.
• Reviews activities related to Design Verification, Design Validation and Design Transfer during development of medical devices and combination products.
• Provides quality and technical support for the evaluation of change assessments for medical devices and combination products.
• Authors, leads and contributes to Risk Management activities including FMEAs.
• Reviews and coordinates with QA and various laboratory groups for test method development and test method validations.
• Ensures proper justification of statistical analysis and hypothesis testing.
• Aids in establishing proper statistical controls in development and transfer to manufacturing processes.
• Supports scientific, complaint and test failure investigations for medical devices and combination products.
• Supports updates to standards and/or new applicable standards.
• Performs tata/statistical/trend analysis as needed.
• Ensures work product meets regulations.
• Writes Quality Procedures, as applicable.

Education

Bachelor's degree in Engineering

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. The Medical Device Quality Engineer provides Quality Assurance support and guidance to ensure compliance in support of combination products for biological therapeutics developed in-house and in collaboration with partners and CMO's.

When & where:

Location: East Greenbush, New York, United States

Work model: Monday-Friday, 8:00 am - 4:30 pm

Discover your role:

• Reviews and supports Design and Development documentation for compliance to internal procedures and regulations.
• Reviews activities related to Design Verification, Design Validation and Design Transfer during development of medical devices and combination products.
• Provides quality and technical support for the evaluation of change assessments for medical devices and combination products.
• Authors, leads and contributes to Risk Management activities including FMEAs.
• Reviews and coordinates with QA and various laboratory groups for test method development and test method validations.
• Ensures proper justification of statistical analysis and hypothesis testing.
• Aids in establishing proper statistical controls in development and transfer to manufacturing processes.
• Supports scientific, complaint and test failure investigations for medical devices and combination products.
• Supports actions required because of updates to standards and/or new applicable standards.
• Supports and contributes to CI initiatives for Med Device Quality.
• Performs tata/statistical/trend analysis as needed.
• Ensures work product meets regulations.
• Writes Quality Procedures, as applicable.

This role requires:

• Bachelor's degree in engineering.
• Experience working in either combination products or medical devices.
• Associate Engineer: 0 - 2 years of experience
• Engineer: 2 years of experience
• Senior Engineer: 5 years of experience

Does this sound like you?

We are committed to building a workplace with an inclusive culture.

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$66,200.00 - $143,900.00