IVD Systems Engineer Job at BEPC Inc. - Business Excellence Professional Consulting, Pleasanton, CA

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  • BEPC Inc. - Business Excellence Professional Consulting
  • Pleasanton, CA

Job Description

Job Title: IVD Systems Engineer

Location: Onsite – Local Candidates Only

Employment Type: Contract

Pay Rate: $60 - $65/hr

Role Overview:

BEPC is seeking a highly experienced IVD Systems Engineer to join our client's System Development team. In this role, you will lead the design and development of innovative in-vitro diagnostic (IVD) automation systems, driving cross-functional collaboration throughout the product lifecycle. This includes requirement development, risk management, validation testing, and regulatory compliance—all while mentoring junior engineers.

Key Responsibilities:

  • Lead development and integration of automated IVD systems.
  • Translate customer needs into systems-level requirements.
  • Execute risk management activities per ISO 14971.
  • Plan and perform system validation and verification.
  • Produce compliant documentation and project deliverables.
  • Troubleshoot system defects and manage changes.
  • Ensure alignment with applicable regulatory and quality standards.
  • Promote process improvements and best practices across teams.
  • Mentor and guide junior systems engineers.
  • Support regulatory submission efforts and audits.

Qualifications:

  • Bachelor’s in Systems, Biomedical, Electrical Engineering, or related field; advanced degree preferred.
  • 5+ years in the medical device industry, preferably in IVD systems.
  • Familiarity with liquid handling platforms (e.g., Hamilton, Tecan) is a plus.
  • Strong experience with requirements development and design inputs.
  • Expertise in ISO 14971 and systems risk management.
  • Excellent problem-solving, analytical, and communication skills.

Job Tags

Contract work, Local area,

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