How Remoteville checks and expires listings
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