Medical Device Quality Engineer

Regeneron Pharmaceuticals • Rensselaer, IN

3d • $66,200 - $143,900

About The Position

The Medical Device Quality Engineer provides Quality Assurance support and guidance to ensure compliance for combination products supporting biological therapeutics developed in-house and in collaboration with partners and contract manufacturing organizations. The role supports design and development, testing, risk management, manufacturing transfer, investigations, and continuous improvement for medical devices and combination products. The position is located in East Greenbush, New York, and is scheduled Monday through Friday, 8:00 a.m. to 4:30 p.m.

Requirements

• Bachelor’s degree in engineering.
• Experience working in either combination products or medical devices.

Responsibilities

• Review and support Design and Development documentation for compliance with internal procedures and regulations.
• Review activities related to Design Verification, Design Validation, and Design Transfer during medical device and combination product development.
• Provide quality and technical support for evaluation of change assessments for medical devices and combination products.
• Author, lead, and contribute to Risk Management activities, including FMEAs.
• Review and coordinate with Quality Assurance and laboratory groups on test method development and validation.
• Ensure proper justification of statistical analysis and hypothesis testing.
• Help establish appropriate statistical controls in development and manufacturing transfer processes.
• Support scientific, complaint, and test failure investigations for medical devices and combination products.
• Support actions required by updates to standards or newly applicable standards.
• Support and contribute to continuous improvement initiatives for Medical Device Quality.
• Perform data, statistical, and trend analysis as needed.
• Ensure work products meet applicable regulations.
• Write Quality Procedures as applicable.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

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