BioSpace
Design Quality Engineer (Medical Device)
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.
Typical Responsibilities
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
Who This Role Might Be For
You have knowledge of the combination device development process
You have experience with device risk management activities
You have a quality mind‑set
Role Requirements 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:
Associate Quality Engineer: 0–2 years
Quality Engineer: 2+ years
Sr. Quality Engineer: 5+ years
Level is determined based on qualifications relevant to the role.
Salary Range (annually) $65,200.00 – $141,800.00
Benefits We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Equal Opportunity Employment 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
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Typical Responsibilities
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
Who This Role Might Be For
You have knowledge of the combination device development process
You have experience with device risk management activities
You have a quality mind‑set
Role Requirements 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:
Associate Quality Engineer: 0–2 years
Quality Engineer: 2+ years
Sr. Quality Engineer: 5+ years
Level is determined based on qualifications relevant to the role.
Salary Range (annually) $65,200.00 – $141,800.00
Benefits We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Equal Opportunity Employment 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
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