System Engineer

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$55.00/yr - $65.00/yr

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Pay Rate: 55-65/hr

Employment Type: W-2 (No C2C)

Position Overview:

We are seeking a Systems Engineer III to support cross-functional R&D teams in the development and lifecycle management of complex medical devices. This role is essential in translating user and business needs into system-level requirements, leading verification and validation efforts, and ensuring compliance with industry standards and regulations.

The ideal candidate will bring strong systems engineering knowledge, a collaborative spirit, and hands-on experience in the full product development lifecycle within the medical device industry.

Key Responsibilities:

• Translate voice of customer and stakeholder needs into system and product requirements.
• Lead or support system architecture definition and integration of subsystems (mechanical, electrical, software, algorithmic).
• Conduct system-level risk assessments, hazard analysis, and define mitigation strategies.
• Drive and execute system-level verification and validation activities.
• Collaborate cross-functionally to resolve system-level issues in both new development and in-market product support.
• Support experimental design, data analysis, and technical decision-making throughout the development lifecycle.
• Ensure compliance with regulatory and safety standards across all phases of product development.
• Apply systems engineering best practices including requirements management, architectural modeling, and FMEA.
• Support continuous improvement initiatives within the Systems Engineering function.

Required Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline);
  Master’s degree preferred.
• Minimum of 3 years of relevant experience in systems engineering or related technical roles within the medical device industry.
• Demonstrated experience in one or more of the following:
  Requirements Management, Systems Integration, Risk Management, FMEA, Design for Six Sigma, Verification & Validation.
• Strong technical writing and verbal communication skills.
• Proven ability to work both independently and collaboratively within cross-functional teams.

Preferred Qualifications:

• Hands-on experience with signal processing and/or algorithm development.
• Familiarity with clinical environments and medical device usage.
• Experience with experimental design and statistical analysis tools.
• Exposure to regulatory standards such as ISO 13485, IEC 60601, and FDA 21 CFR Part 820.

• Seniority level
  
  Mid-Senior level

• Employment type
  
  Contract

• Job function
  
  Information Technology
• Industries Medical Equipment Manufacturing

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Medical insurance

Vision insurance

401(k)

Pension plan

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San Diego, CA $-$ 10 hours ago

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