Quality Engineer II
17011 Red Hill Avenue Irvine, CA 92614 US
Job Description
The Critical Care (CC) business unit is currently seeking a talented Quality Engineer in New Product Development role supporting the development of new and innovative hemodynamics monitoring platforms. This Quality Engineer (QE) will work in a fast-paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
Job Function:
- Apply new product development knowledge and quality engineering principles to ensure compliance with regulatory requirements.
- Focus on Design Control, Design Verification, Design Validation, Specification Development, and Test methods.
- Develop, update, and maintain technical content of risk management files. Perform Failure Mode and Effects Analysis to identify product risks.
- Apply statistical knowledge in developing Statistical Reliability tests and statistical sampling plans. Critical review and approval of design specifications and design changes; partner with R&D in the design of safe and effective Critical Care (CC) devices; partner with Manufacturing Engineering to develop critical manufacturing processes and provide technical quality engineering support for pilot production of CC devices Evaluate and review complex experiments and tests to create, validate, and improve products
Required Education & Skills
Bachelor's Degree in Engineering (Electrical preferred, Biomedical, or Mechanical) + minimum of 2 years of industry experience OR Master's Degree in Engineering + minimum of 1 years of industry experience Strong understanding of FDA medical device regulations. Design Control knowledge is a plus Must be able to work in a team environment, including inter-departmental teams. Ability to interact professionally with different functional groups including R&D, Regulatory, Operations, and Clinical Affairs. Experience working with R&D to affect design for manufacturing, mistake-proofing and robust design transfer to manufacturing Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Knowledge of Electronics, IEC-60601 standard, and systems engineering is a plus.
- Working knowledge and understanding of statistical techniques. Strong ability to identify, interpret, and apply statistical sampling methods. Ability to manage competing priorities in a fast paced environment Strong problem-solving, organizational, analytical and critical thinking skills
- Ability to identify and describe quality system documentation components, including quality policies and procedures CQE (Certified Quality Engineer) or 6 sigma Black Belt certification are a plus
- Demonstrate troubleshooting skills and capability in evaluating process changes and/or nonconformance for risk management or for developing technical justifications.
**salary will be commensurate with experience**
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