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IEC 62304 Remote Jobs

11 fresh jobs found

Quality Engineer - SaMD
Remote, United States

Medical device QMS Nonconformance evaluations External audits FDA CFR 21 820 21 CFR Part 820 Design Validation Process controls Internal Audits Design verification +51

USD 84K+

Software Design Assurance Quality Engineer
US Remote, United States

Medical device standards Firmware Development Software validation IEC 62304 Design control Medical device industry Neuromodulation ISO 13485 Medical Technology +20

USD 115K+

Director, Systems Engineering (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

FTA Usability Engineering PHA Verification Plans HRAs Human Factors Engineering 21 CFR Part 820.30 Traceability Regulatory Approval +33

Exec Senior Full Time

USD 181K+

Senior Software Manager
Minnesota, Minneapolis Virtual Address, United States

Biomedical application development Software management Medical device software Software lifecycle Managerial IEC 62304 Healthcare Market Knowledge M Talent Management +24

Senior Full Time

USD 149K+

Senior Software Systems Engineer (Remote/Flexible)
US - California (San Diego - Office), United States

Insulet Corporation

Helix alm Polarion alm 21 CFR Part 820.30 Requirements writing DOORS FDA guidelines Traceability IEC 62304 Design Controls +41

Senior Full Time

USD 109K+

Principal Product Security Engineer (REMOTE)
Michigan, Virtual Address, United States

Security maturity frameworks ISO 81001-5-1 Secure Development IEC 62304 Security assessments MITRE ATT&CK Product Lifecycle Security frameworks Quality Management Systems +37

Senior Full Time

USD 129K+

Software Quality Assurance Engineer
Remote - Texas, United States

Solventum Remote-first

C language Medical device software Gap Assessments Software configuration management IEC 62304 Software Configuration Software Quality Assurance ISO 14971 Task Management +29

Senior Mid Full Time

USD 95K+

Senior Systems Engineer (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

Hazards and risk assessments Hazards assessment Helix alm Design trade-off analysis Polarion alm Protocol writing Design Trade-off Verification planning Traceability +54

Senior Mid Full Time

USD 99K+

Sr Systems Engineer (Remote/Flexible)
US - California (San Diego - Office), United States

Insulet Corporation

Hazards and risk assessments Cloud-based products Concept generation Enterprise system performance Performance models Grey box testing Design Trade-off HTTP protocols Non-functional requirements +37

Senior Mid Full Time

USD 109K+

Senior Software Systems Engineer (Remote/Flexible)
US - California (San Diego - Office), United States

Insulet Corporation

Traceability Communication technology Requirements writing Design Controls 21 CFR Part 820.30 QMS FDA guidelines IEC 62304 Software Requirements +35

Senior Full Time

USD 109K+

Senior Software Systems Engineer
US - California (San Diego - Office), United States

Insulet Corporation

Communication technology Helix alm Polarion alm Traceability Requirements writing Design Controls 21 CFR Part 820.30 DOORS QMS +40

Senior Full Time

USD 99K+

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