Job Description:
A leading Medical Device company are actively seeking a motivated candidate to fill their Sr Engineer role. This is an initial 3-month contract role with opportunity to extend/ convert to FTE.
This is an onsite role based in Irvine, CA with travel of up to 25% included. Full- time standard office hours. Salary range between $58-63 /hour depending on experience.
Education/Experience:
- B.S. degree in Mechanical, Biomedical engineering or related and 5-7 years experience required.
- Demonstrated engineering experience in Supplier Quality, Supplier Development, New Product Development, or Manufacturing Engineering in medical device or other regulated industry.
- Knowledge of complex catheter and implant manufacturing preferred.
- Experience with the use of statistical techniques, Six Sigma tools, and DMAIC problem solving techniques.
- Knowledge and understanding of FDA's 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards preferred.
Responsibilities:
- Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, and component capability assessments.
- Lead risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers.
- Support suppliers in the development, approval and execution of process validation protocols and reports for critical processes.
...
