Lead Systems Engineer (Med Devices Product Development | IEC 62304 | JAMA)

Entegee; Thousand Oaks (CA); Hybrid; USD 96,432 - 123,984; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Disability insurance

Pension plan

Job summary

A leading technology company seeks a Lead Systems Engineer in the Greater San Fernando Valley, CA area. The ideal candidate will have extensive experience in medical devices and requirements management, alongside a relevant engineering degree. Responsibilities include managing systems engineering tasks and ensuring compliance with software design standards. This full-time position offers competitive pay and benefits including medical insurance and retirement plans.

Qualifications

• 5-10 years experience as Lead or Principal Systems Engineer.
• Experience with IEC 62304 Software Life-Cycle Standard.
• Medical device industry experience highly preferred.

Responsibilities

• Lead or principal systems engineer executing various systems engineering tasks.
• Perform technical planning, system integration, verification and validation.
• Analyze concept, design, fabrication, and total system product.

Skills

Requirements Management (JAMA)

Software Design

Medical Device Development

IEC 62304 Software Life-Cycle Standard

System Integration

Education

MSEE/BSEE or MSCS/BSCS

Job description

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.

Responsibilities

• 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.

Requirements

• 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.

Additional Responsibilities

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

Contact

Bob A. Russ, MBA

Software | Systems | CyberSecurity | Data Science | IoT

(DoD | Aerospace | Medical Devices)

M: 818.568.6948

World Leader in IT and Engineering Workforce Solutions

Equal Opportunity Employer / Veterans / Disabled

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Engineering, Science, and Information Technology

Industries

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

Benefits

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