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Client:
Leading Medical Device Manufacturer
Position:
Principal Software Quality Engineer⏳
Duration:
6+ Months (Possible Extension)
Location:
Remote (U.S.)
About the Role We are seeking a
Principal Software Quality Engineer
to provide technical leadership and quality oversight for
software and hardware product development
within a regulated
medical device environment . This role is ideal for someone who thrives in a cross-functional setting, ensuring compliance, innovation, and patient safety across the full product lifecycle.
Key Responsibilities
Lead
Quality Engineering
activities across software and hardware development teams, ensuring compliance with design control and risk management processes.
Develop and maintain the
Risk Management File (RMF)
including hazard analyses, dFMEAs, pFMEAs, and related documentation.
Provide quality input and approvals for
Design History Files (DHF) , including design inputs, verification & validation, and test planning documentation.
Drive
software quality best practices —including code reviews, software security assessments, and software BOM oversight.
Offer statistical expertise in
test method validation
and design verification/validation.
Participate in
design reviews
to ensure effective product transfer from R&D to production.
Support
CAPA management , audit readiness, and process improvements related to design controls and quality systems.
Collaborate on software anomaly resolution (e.g., bugs, cybersecurity vulnerabilities) and guide remediation efforts.
Required Qualifications
8+ years of progressive
Quality Engineering experience
in the
medical device industry , supporting both
hardware and software development .
Strong knowledge of regulatory and quality standards, including: FDA 21 CFR 820 ,
ISO 13485 ,
ISO 14971 ,
IEC 60601 ,
IEC 62304 , and
IEC 62366 .
Proven experience in
design verification/validation ,
risk management , and
software lifecycle processes .
Proficiency with
statistical analysis tools
(e.g., Minitab) and
quality system management (QMS) .
Excellent communication, problem-solving, and leadership skills with the ability to influence cross-functional teams.
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Client:
Leading Medical Device Manufacturer
Position:
Principal Software Quality Engineer⏳
Duration:
6+ Months (Possible Extension)
Location:
Remote (U.S.)
About the Role We are seeking a
Principal Software Quality Engineer
to provide technical leadership and quality oversight for
software and hardware product development
within a regulated
medical device environment . This role is ideal for someone who thrives in a cross-functional setting, ensuring compliance, innovation, and patient safety across the full product lifecycle.
Key Responsibilities
Lead
Quality Engineering
activities across software and hardware development teams, ensuring compliance with design control and risk management processes.
Develop and maintain the
Risk Management File (RMF)
including hazard analyses, dFMEAs, pFMEAs, and related documentation.
Provide quality input and approvals for
Design History Files (DHF) , including design inputs, verification & validation, and test planning documentation.
Drive
software quality best practices —including code reviews, software security assessments, and software BOM oversight.
Offer statistical expertise in
test method validation
and design verification/validation.
Participate in
design reviews
to ensure effective product transfer from R&D to production.
Support
CAPA management , audit readiness, and process improvements related to design controls and quality systems.
Collaborate on software anomaly resolution (e.g., bugs, cybersecurity vulnerabilities) and guide remediation efforts.
Required Qualifications
8+ years of progressive
Quality Engineering experience
in the
medical device industry , supporting both
hardware and software development .
Strong knowledge of regulatory and quality standards, including: FDA 21 CFR 820 ,
ISO 13485 ,
ISO 14971 ,
IEC 60601 ,
IEC 62304 , and
IEC 62366 .
Proven experience in
design verification/validation ,
risk management , and
software lifecycle processes .
Proficiency with
statistical analysis tools
(e.g., Minitab) and
quality system management (QMS) .
Excellent communication, problem-solving, and leadership skills with the ability to influence cross-functional teams.
#J-18808-Ljbffr