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

Similar Jobs