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ISO 14971 Remote Jobs

21 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+

Staff Regulatory Affairs Specialist
Remote US

SOP Authoring AI/ML in Healthcare Global Product Registration Submission Preparation Compliance review Regulatory Intelligence Wearable technology 21 CFR 820 EU MDR +20

Senior Full Time

USD 124K+

Sr Systems Engineer I (Mobile)
San Diego, California, United States

Tandem Diabetes Care

Failure analysis Requirements development Bluetooth Diabetes technology ISO 14971 Test planning Diabetes Care Mobile applications Diabetes +15

Senior Mid Full Time

USD 95K+

Systems Engineer II (Software Updates)
San Diego, California, United States

Tandem Diabetes Care

Design trade-off analysis Failure analysis Hazard Analysis Test Plan Development Traceability Diabetes technology ISO 14971 Requirements Management Cost-benefit analysis +18

USD 80K+

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+

Principal Regulatory Affairs Specialist/Engineer (SaMD)
Virtual US

Cleerly Remote-first

De novo requests CE marking 510k FDA Submissions Sheets Regulatory strategy ISO 14971 Drive FDA regulations +32

Senior Full Time

USD 179K+

Sr. Quality System Specialist (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

Quality system regulation Traceability Document Control ISO 14971 QMS Quality Management Systems ISO 13485 FDA regulations ISO +25

Senior Mid Full Time

USD 89K+

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+

Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent)
USA - New Jersey - Rahway, United States

Tensile testing ISTA ASTM FDA guidance Machining Manufacturing process development 21 CFR 820 3D CAD Drug product development +88

Senior Mid Full Time

USD 139K+

Sr. Scientist, Device Design Engineer
USA - New Jersey - Rahway, United States

CAE ISTA Tensile testing Dfm Design input requirements ArtiosCAD Tolerance stack ups Dfa ASTM +80

Senior Mid Full Time

USD 114K+

Principal Scientist, Device Product and Process Development (Director Equivalent)
USA - New Jersey - Rahway, United States

Risk-oriented development Structural finite element analysis Measurement techniques Design failure modes and effects analysis In silico modeling Device characterization FDA guidance Device technology Mechanical Testing +70

Senior Full Time

USD 153K+

Senior Principal Device Technical Working Group Lead (Senior Director Equivalent)
USA - New Jersey - Rahway, United States

Human factors analysis Injection molding Automated assembly EN 62366 Device design Device technology Quality system regulation Medical device development Manufacturing process development +78

Senior Full Time

USD 169K+

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+

Associate Director, Quality Assurance - Remote
USA - New Jersey - Rahway, United States

Purchasing controls Preventive action 21cfr820 ICH Q9 21cfr part 4 Combination product development Design Controls Good manufacturing practice Device development +76

Senior Mid Full Time

USD 139K+

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+

Associate Principal Scientist (Associate Director Equivalent), Device Risk Management
USA - New Jersey - Rahway, United States

Empirical evidence Risk control measures Post market surveillance Combination product development Hazard Analysis Device development Clinical evaluations Process Enhancement ISO 14971 +53

Senior Mid Full Time

USD 139K+

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+

Sr Regulatory Affairs Specialist (Remote)
USA-CA Northridge, United States

Digital Health Apps Change Notifications Engineering Change Requests Submission Preparation Global Regulatory Strategies Regulatory Documentation Medical Device Regulations ISO 14971 Labeling +36

Senior Full Time

USD 133K+

Senior Human Factors Design Engineer
USA-CA Northridge, United States

IEC 62366 FDA guidance IEC 60601 Medical Device Design Human factors Regulatory Documentation Design Documentation ISO 14971 Healthcare Access +23

Senior Mid Full Time

USD 171K+

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