Immediate Job Opening - Design Assurance Engineer (Medical Device) - MN Apply
Hi, Please find the below job description, if you are interested in this position, send me your updated resume to saichandra@intellectt.com. Thank You.
Role: Design Assurance Engineer
Location: Plymouth, MN
Duration: 12+ Months on W2
Top Skills:
- Design validation experience
- Experienced Design Assurance Engineer
- Medical device experience
- Staff Level
- Medical device experience
- BA technical degree
- 7-9 years of experience
- New product development in R&D
- Product requirement drafting experience
- Design validation experience
- Design Verification
- Technical
Job Description:
1. Ensure the company's 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 the 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 the 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.
