Senior Systems Engineer

Roche

Santa Clara, California, US
Base: $83,900.00 - $125,000.00; bonus/equity: disc...
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5+ years medical device experience
Iso 14971 risk management expertise
Ivd system development background
** Roche is seeking a Senior Systems Engineer to join their System Development team in Santa Clara, California. The role involves developing novel In Vitro Diagnostics (IVD) automated systems and requires expertise in medical device development, regulatory compliance, and mentoring junior engineers. **

Job Summary

  • This role focuses on developing novel In Vitro Diagnostics (IVD) automated systems within a culture that values personal expression and genuine connections.
  • The engineer will provide technical expertise to cross-functional teams to ensure products meet customer requirements and regulatory standards throughout the lifecycle.
  • Relocation benefits are not available for this position, but a discretionary annual bonus may be offered based on performance.

Matching Summary

Match Score: 75

** Roche is seeking a Senior Systems Engineer to join their System Development team in Santa Clara, California. The role involves developing novel In Vitro Diagnostics (IVD) automated systems and requires expertise in medical device development, regulatory compliance, and mentoring junior engineers. **

Salary

Base: $83,900.00 - $125,000.00; Bonus/Equity: Discretionary annual bonus available; Benefits: Standard company benefits package

Skills & Requirements

Must-have

  • 5+ years medical device experience
  • ISO 14971 risk management expertise
  • IVD system development background
  • Product requirements definition skills
  • Verification and validation execution

Nice-to-have

  • Hands-on liquid pipetting systems
  • Hamilton or Tecan experience
  • Mentoring junior engineers
  • FDA submission support
  • Continuous process improvement

Key Requirements

  • Bachelor's degree in Engineering
  • Advanced degree preferred
  • 5+ years professional experience
  • Experience with ISO 14971
  • On-site work in Santa Clara

Work Rights

Not specified

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