A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance efforts to ensure that the companys products conform to quality standards. You will partner with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes. The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices. Essential Functions:
1. Ensure companys adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
2. Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.
3. Manage new product Design History Files.
4. Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
5. Aide in definition of test equipment as required to accomplish quality responsibilities.
6. Develops and documents test plan protocols, test procedures, and test reports.
7. Perform tests according to various protocol requirements.
8. Lead completion of risk management and risk analysis including FMEA.
9. Devise design verification and design validation plans for products based on performance specifications and risk analysis
10. Analyze and communicate conformance to specifications and standards.
11. Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
12. Support completion of in vitro testing including applicable animal studies.
13. Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
14. Assist in specifications and testing of sterilization methods.
15. Lead system and product continuous improvement teams.
16. Reviews Engineering Change Orders, as required.
17. Perform other duties and responsibilities as assigned by senior management.