Systems Engineering Manager

3 days ago


Irvine, California, United States Oncocyte Corporation Full time
We are seeking a highly skilled Systems Engineering Manager to join our team at Oncocyte Corporation. As a Systems Engineering Manager, you will play a key role in defining product strategy, scope, and launch decisions for IVD products. Your expertise will ensure seamless integration of IVD products from a system level by collaborating with internal and external stakeholders. You will work cross-functionally to guarantee the availability of commercial, technical, regulatory, manufacturing, and logistics resources to support the successful execution of product strategy in IVD markets. The ideal candidate will have a Master's degree or higher in engineering, biological science, physics, or chemistry and 5+ years of system-level integration and validation experience with a strong understanding of medical device design controls and change controls. Proficiency with Design Controls and Risk Management is essential. Experience mentoring and leading teams of technical contributors is also required. The estimated salary for this position is $120,000 - $180,000 per year, depending on experience.

Responsibilities:
  1. Collaborate with subject matter experts internally and externally from diverse fields to support OCX's diagnostics product portfolio from concept through development, verification and validation, design transfer, manufacturing, and commercialization.
  2. Lead the definition and management of requirements and characterization of systems/devices.
  3. Define, plan, and coordinate formal technical design reviews.
  4. Lead system integration across multi-functional subject areas.
  5. Lead risk management and hazard analysis activities.
  6. Lead FMEA document generation in design, process, user error, and software.
  7. Maintain system traceability matrix.
  8. Support failure mode analysis and troubleshooting.
  9. Coordinate with external vendors and CMOs to maintain production timeline and logistics.
  10. Support in the design transfer to manufacturing.
  11. Coordinate with external partners and consultants to ensure proper IVD SW development and V&V under FDA QMS and ISO13485 guidance.
  12. Write system-related documents such as SOPs, QC, and IQ/OQ/PQ under the IVD product lifecycle.
  13. Support the regulatory submissions, product labeling, and complex submissions issues.

About You:
We are looking for an exceptional individual who is passionate about delivering high-quality solutions in the field of systems engineering. If you have a strong background in engineering, biological science, physics, or chemistry and experience in system-level integration and validation, we would like to hear from you. As a member of our team, you will have the opportunity to work on challenging projects, collaborate with talented professionals, and grow your skills and expertise. The estimated salary for this position is $120,000 - $180,000 per year, depending on experience.

Contact Information:
Please submit your resume and cover letter to apply for this exciting opportunity.

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