Design Assurance Engineer
Are you looking for an opportunity to continue to grow your career in the Medical Device Industry? Our client is looking for a Design Assurance Engineer.
Schedule: 1st shift, Monday – Friday, 40hrs, (6+ month Temp/Contract)
In this role you will be responsible for providing Quality Assurance support and leadership to ensure compliance in the support of the medical device development life cycles.
Duties and Responsibilities include, but are not limited to:
- Review Design and Development paperwork, records, etc. for compliance
- Ensure proper justification of statistical analysis and hypothesis testing
- Contribute to technical protocols, reports and documents for Design History Files
- Lead the device risk management activities including UFMEA, DFMEA, PFMEA
- Aid in establishing and maintaining proper statistical controls in development and transfer to manufacturing processes
- Verity data integrity, electronic data storage and data sheet validations
- Review and coordinate with QA Validation for all test method and design validations
- Review activities related to Design Verification and Design Transfer of Medical Devices
- Ensure work product meets regulations
- Support scientific, complaint, and test failure investigations
- Perform data trend analysis, where applicable
- Participate in Phase Reviews
- Perform Data/Statistical analysis as needed.
- BS in Engineering (ie Sr Quality Engineer) and 5-8 years of experience in the combination device or medical device industry
- Excellent verbal and written communication skills
- Ability to work independently
- Ability to build strong working relationships with multiple departments
- Experience with Class II and/or Class III medical devices