SPECTRAFORCE
Direct message the job poster from SPECTRAFORCE
Sr. Principal Software Quality Engineer
Location:
Bellevue, WA (Hybrid – 3 days onsite per week)
⏱️
Duration:
6 Months (Possibility of extension or temp-to-hire)
About the Role
We are seeking an experienced
Sr. Principal Software Quality Engineer
to provide leadership and quality oversight for both hardware and software product development within the medical device industry. This individual will play a key role in design control, risk management, and regulatory compliance to ensure delivery of safe and effective products
Key Responsibilities
Lead
Quality Engineering activities
for new product development, including design control and risk management.
Develop and maintain
Risk Management Files (RMF)
— risk plans, hazard analysis, dFMEA, pFMEA, and risk reports.
Review and approve
Design History Files (DHF)
and related documentation.
Provide guidance on
statistical methods , design verification/validation, and test method validation.
Serve as the
subject matter expert (SME)
for software quality, participating in code reviews, software security analysis, and BOM reviews.
Support triage and remediation of
software bugs, cybersecurity vulnerabilities, and production issues .
Drive
continuous improvement
in quality processes and compliance with regulatory standards.
Required Qualifications
8+ years
of progressive
Quality Engineering experience
in the
medical device industry .
Hands-on experience supporting
hardware and software development
(embedded and non-embedded).
Strong knowledge of regulatory standards:
FDA CFR 820 ,
ISO 13485 ,
ISO 14971 ,
IEC 60601 ,
IEC 62304 , and
IEC 62366 .
Expertise in
risk management ,
design verification/validation , and
statistical analysis tools (e.g., Minitab) .
Excellent
communication, documentation, and problem-solving skills .
Bachelor’s or Master’s degree in
Biomedical, Software, Electrical, or related Engineering field .
Preferred Qualifications
ASQ CQE
and/or
Six Sigma Green/Black Belt
certification.
Experience with
AI/algorithm development ,
AAMI TIR45 framework ,
SaMD , or
cloud infrastructure .
#J-18808-Ljbffr
Sr. Principal Software Quality Engineer
Location:
Bellevue, WA (Hybrid – 3 days onsite per week)
⏱️
Duration:
6 Months (Possibility of extension or temp-to-hire)
About the Role
We are seeking an experienced
Sr. Principal Software Quality Engineer
to provide leadership and quality oversight for both hardware and software product development within the medical device industry. This individual will play a key role in design control, risk management, and regulatory compliance to ensure delivery of safe and effective products
Key Responsibilities
Lead
Quality Engineering activities
for new product development, including design control and risk management.
Develop and maintain
Risk Management Files (RMF)
— risk plans, hazard analysis, dFMEA, pFMEA, and risk reports.
Review and approve
Design History Files (DHF)
and related documentation.
Provide guidance on
statistical methods , design verification/validation, and test method validation.
Serve as the
subject matter expert (SME)
for software quality, participating in code reviews, software security analysis, and BOM reviews.
Support triage and remediation of
software bugs, cybersecurity vulnerabilities, and production issues .
Drive
continuous improvement
in quality processes and compliance with regulatory standards.
Required Qualifications
8+ years
of progressive
Quality Engineering experience
in the
medical device industry .
Hands-on experience supporting
hardware and software development
(embedded and non-embedded).
Strong knowledge of regulatory standards:
FDA CFR 820 ,
ISO 13485 ,
ISO 14971 ,
IEC 60601 ,
IEC 62304 , and
IEC 62366 .
Expertise in
risk management ,
design verification/validation , and
statistical analysis tools (e.g., Minitab) .
Excellent
communication, documentation, and problem-solving skills .
Bachelor’s or Master’s degree in
Biomedical, Software, Electrical, or related Engineering field .
Preferred Qualifications
ASQ CQE
and/or
Six Sigma Green/Black Belt
certification.
Experience with
AI/algorithm development ,
AAMI TIR45 framework ,
SaMD , or
cloud infrastructure .
#J-18808-Ljbffr