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Principal Quality Engineer
2 months ago
We are seeking a highly skilled Principal Quality Engineer to join our team at Edwards Lifesciences. As a key member of our Critical Care division, you will play a critical role in ensuring compliance with regulatory requirements and optimizing product development, manufacturing, and distribution.
Key Responsibilities- Lead design assurance and development activities, including requirement development, risk assessment, and engineering study.
- Provide engineering solutions in Quality Assurance, Design Control, Risk Management, and Statistical Techniques.
- Develop, update, and maintain technical content of risk management files.
- Collaborate cross-functionally to facilitate the successful execution of the NPD process and launching of robust products.
- Develop and validate complex experiments and tests to create, validate, and improve products and manufacturing processes.
- Investigate complex manufacturing product quality and compliance issues.
- Lead identification, development, and optimization of design verification activities and complex manufacturing processes.
- Bachelor's Degree in Engineering or Scientific field, 6 years experience, or Master's Degree or equivalent in Engineering or Scientific field, 5 years experience, or Ph.D. or equivalent in Engineering or Scientific field, 2 years experience.
- Hands-on experience with Design Assurance, including Design Controls, Design Freeze, Design Verification & Validation, and/or Design Test Method Development.
- Experience working within a highly regulated industry.
- Knowledge of and experience with Risk Management/Usability Engineering and authoring risk management documents.
- Demonstrated technical leadership, including solving complex problems and implementing process improvements.
- In-depth working knowledge and understanding of statistical techniques.
- Ability to read and interpret drawings.
- Ability to translate technical information to all levels of the organization.
- Test Method Development and Validation Experience.
- Working knowledge of Domestic and International regulatory requirements of Medical Device regulations.
We offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $115,000 to $163,000 (highly experienced). The pay for the successful candidate will depend on various factors, including qualifications, education, and prior experience.
Edwards Lifesciences is an Equal Opportunity/Affirmative Action employer, including protected Veterans and individuals with disabilities.
We are committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.
