System Engineer

A-Line Staffing Solutions

San Diego (CA)

On-site

USD 110,000 - 140,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Pension plan

Job summary

A-Line Staffing Solutions is looking for a Systems Engineer III to support R&D in developing complex medical devices. The ideal candidate will have strong systems engineering knowledge and experience in the medical device industry, ensuring compliance with standards while effectively collaborating with teams. This role offers a competitive salary and the opportunity to contribute to innovative healthcare solutions.

Qualifications

3 years of relevant experience in systems engineering or related roles in the medical device industry.
Demonstrated experience in requirements management, systems integration and verification.
Strong communication skills with both independent and collaborative working ability.

Responsibilities

Translate user needs into system requirements and lead verification activities.
Conduct risk assessments and ensure compliance with industry standards.
Collaborate across functions to resolve system-level issues in product development.

Skills

Requirements Management

Systems Integration

Risk Management

FMEA

Technical Writing

Collaboration

Education

Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline)

Master’s degree preferred

Job description

A-Line Staffing Solutions provided pay range

This range is provided by A-Line Staffing Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$55.00/yr - $65.00/yr

Direct message the job poster from A-Line Staffing Solutions

Information Technology Recruiter at A-Line Staffing Solutions

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