Senior Systems Engineer (Verification & Validation/ Liquid Handling Systems)

ZipRecruiter; Santa Clara (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

A dynamic opportunity with a leading firm in diagnostics and life sciences seeks a Senior Systems Engineer in Santa Clara. This long-term contract role focuses on developing innovative IVD automated systems, requiring strong technical collaboration, regulatory compliance, and mentoring of junior engineers. Ideal candidates will possess a solid educational background and extensive experience in the medical device field.

Benefits

Medical

Dental

Vision

Paid Sick leave

401K

Qualifications

• 5+ years of experience in the medical device industry, preferably in IVD.
• Hands-on experience with liquid pipetting systems.
• Ability to develop product requirements and design inputs.

Responsibilities

• Develop and manage systems level product requirements for IVD systems.
• Lead verification/validation activities ensuring design meets customer requirements.
• Maintain knowledge of current regulatory requirements for medical devices.

Skills

Technical expertise

Collaboration

Project management

Education

Bachelor’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering

Advanced degree

Tools

Liquid pipetting systems (Hamilton, Tecan)

Job description

Job DescriptionJob Description

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
• 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 [e-mail]/[e-mail]