Lead Systems Engineer; Med Devices Product Development | IEC | JAMA

Job Overview

Lead Systems Engineer (Hybrid) – Greater San Fernando Valley, CA area

(Medical Devices | New Product Development | Requirements Management | JAMA | IEC 62304 | Software Design History File Management)

US Citizenship, Green Card (permanent resident), or EAD required.

MSEE/BSEE, MSCS/BSCS or related 4‑year degree required.

Local to Greater San Fernando Valley, CA area only.

Base pay range: $70.00/hr – $90.00/hr additional compensation:
Annual bonus, sign‑on bonus.

• Lead or principal systems engineer executing a variety of Systems Engineering tasks, with expansion into Software Design History File Management.
• Experience with Medical Device product development; not focused on software development, but management of software design history files.
• Perform technical planning, system integration, verification and validation, evaluation of alternatives with cost, risk, supportability and total system analysis.
• Analyze concept, design, fabrication, test, installation, operation, maintenance, and disposal of total system product.
• Perform functional analysis, timeline analysis, detail trade studies, requirements allocation, interface definition studies to translate customer requirements into hardware and software specifications.

• MSCS/BSCS, MSEE/BSEE or related 4‑year degree in engineering or Computer Science.
• 5‑10 years experience as Lead or Principal Systems Engineer with Requirements Management (JAMA) in medical device software design history files.
• 8+ years experience with IEC 62304 Software Life‑Cycle Standard.
• Experience with New Product Development (NPD) for medical devices.
• At least 5 years experience with Medical Device Software.
• Medical device industry experience highly preferred.

• Requirements Management
• Verification Trace Matrices
• Protocol Creation
• Test Execution and Report Creation
• Understanding of Medical Device quality systems; design verification and validation experience.

Bob

A. Russ, MBA

Software | Systems | Cyber Security | Data Science | IoT

(DoD | Aerospace | Medical Devices)

M:

World Leader in IT and Engineering Workforce Solutions

Equal Opportunity Employer / Veterans / Disabled

Mid‑Senior level

Full‑time

Engineering, Science, and Information Technology

Medical Equipment Manufacturing, IT System Testing and Evaluation, and IT System Design Services

• Medical insurance
• Vision insurance
• 401(k)
• Disability insurance
• Pension plan