Overview
On Site
$60 - $65
Contract - W2
Contract - 6 Month(s)
Skills
IVD
Medical Devices
ISO 14971
Job Details
Job Title: Senior Systems Engineer
Location: Onsite Local Candidates Only, PLeasanton, CA
Employment Type: Contract
Pay Rate: $60 - $65/hr
Location: Onsite Local Candidates Only, PLeasanton, CA
Employment Type: Contract
Pay Rate: $60 - $65/hr
Role Overview:
BEPC is seeking a highly experienced Senior 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.
BEPC is seeking a highly experienced Senior 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.
Contract Details:
- Duration: 6 months with possible extensions
- Location: Onsite Local candidates only
About BEPC:
BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.
BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.
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