Design Quality Engineer II
Skills
Acceptance SamplingBiomedical Device DesignDesign ControlDesign HistoryDesign SpecificationsFunctional VerificationMedical Device Manufacturing
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Minimum of a Bachelor’s Degree in an Engineering or science field, or equivalent work experience
- Minimum of 3 years hands-on experience preferably in a FDA regulatory industry
- Specific experience in medical device Design Controls for developing and preparing design specifications
- Specific experience designing, preparing, executing, and statistically analyzing validations and developing report packages
- Specific experience in the application of statistical methods and acceptance sampling within a regulated industry such as medical device manufacturing or pharmaceutical
- Personal computer skills, i.e., word processing, spreadsheets, data analysis
Nice to have
- Risk Management Experience
- ASQ, CQE and CQA certifications
Day to day
- Provide Design Quality Engineering support for NPD and serve on Technical Teams for Aortic programs in design control
- Support regional expansion and bring CE Marked implantable products into the US
- Develop, conduct, and document qualifications/validations to ensure products are reliable, safe, and effective prior to release