Entegee
Lead Systems Engineer (Med Devices Product Development | IEC 62304 | JAMA)
Entegee, Thousand Oaks, California, United States, 91362
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
#J-18808-Ljbffr
(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
#J-18808-Ljbffr