Title: Software Quality Design Engineer
Location: MA, MN
Duration: Long term
Pay Rate: $38 - 43/hr on W2Must-have : 4 5+ years of experience in Software Quality / Quality Engineering / Software Development
Medical device industry experience - highly important
Experience supporting embedded firmware/software development from a Quality perspective
Strong understanding of Software Development Life Cycle (SDLC)
Experience with IEC 62304, ISO 13485, ISO 14971, FDA QMSR
Strong Design Controls, Risk Management, Change Control
Experience with Software FMEA (SW FMEA) and System Hazard Analysis
Experience reviewing software requirements, design documents, code reviews, V&V reports
Able to create risk management reports, SW FMEA, hazard analysis
Experience working with R&D / Quality / Regulatory / Medical Safety teams
*Tools / Technical Keywords**Look for* : Jira
PTC
ALM / Application Lifecycle Management
Embedded Software / Embedded Firmware
Software Verification & Validation
Design Controls
Risk Management
SW FMEA
Hazard Analysis
Requirements Management
Change Control
*Education* BS in Engineering, Science, Biomedical Engineering, Software/Computer Engineering, or related technical field + 4 years
OR MS/Advanced degree + 2 years
Best-fit profileSomeone whose resume looks roughly like:
Software Quality Engineer / Senior Software Quality Engineer Medical Devices
5 10 years experience embedded firmware medical devices IEC 62304 / ISO 14971 / ISO 13485 Design Controls SW FMEA Risk Management V&V Jira/ALM/PTC.
Benefits: This a contract position does not include employer-provided benefits.
Equal Opportunity Employer:
We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to
race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check:
Background checks may be conducted in accordance with applicable law.
Work Authorization:
Applicants must be authorized to work in the United States.