Our client a world leader in diagnostics and life sciences is looking for a "Senior Systems Engineer based out of Santa Clara CA.
Job Duration: Long Term Contract (Possibility Of Further Extension)
Pay Rate: $65/hr on W2
Company Benefits: Medical Dental Vision Paid Sick leave 401K
This Senior Systems Engineer will be part of the System Development team focusing on the development of novel IVD automated systems and end-to-end product solutions. The individual is expected to provide technical and process expertise in collaboration with internal stake holders and cross functional teams throughout total product development lifecycle to develop and maintain medical device products according to customer requirements applicable regulatory and quality standards. This role is expected to lead and mentor less experienced engineers and their career development.
Responsibilities:
- Provide technical expertise to cross-functional teams to develop IVD systems and ensure the product design will meet customer requirements as well as applicable standards and regulations
- Develop and manage systems level product requirements
- Perform product risk management activities
- Develop and execute verification/validation activities and traceability analysis
- Create artifacts required for project deliverables
- Resolve issues found according to company s defect/change tracking process
- Maintain knowledge of current regulatory requirements and standards as they pertain to the development and testing of medical/IVD devices
Qualification & Skills:
- Bachelor s degree in Systems Engineering Biomedical Engineering Electrical Engineering or related disciplines. Advanced degree preferred
- 5 years of professional experience in medical device industry. Experience in IVD industry highly desirable
- Hands-on experience with liquid pipetting systems such as Hamilton Tecan etc. is a plus
- Experience developing product requirements and design inputs
If interested please send us your updated resume at /
V&V, liquid handlers, life sciences, Tecan, Hamilton
Education
Bachelors's degree