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Design Assurance Engineer(Medical device)
1 month ago
Role: Design Assurance Engineer
Location: Plymouth, MN - 55442
Duration: 12 Months
Job Description:
- 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:
- Ensure company's adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
- Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.
- Manage new product Design History Files.
- Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
- Aide in definition of test equipment as required to accomplish quality responsibilities.
- Develops and documents test plan protocols, test procedures, and test reports.
- Perform tests according to various protocol requirements.
- Lead completion of risk management and risk analysis including FMEA.
- Devise design verification and design validation plans for products based on performance specifications and risk analysis
- Analyze and communicate conformance to specifications and standards.
- Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
- Support completion of in vitro testing including applicable animal studies.
- Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
- Assist in specifications and testing of sterilization methods.
- Lead system and product continuous improvement teams.
- Reviews Engineering Change Orders, as required.
- Perform other duties and responsibilities as assigned by senior management.
