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ISO 14971 Remote Jobs

12 fresh jobs found
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Staff Design Assurance Engineer (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

Design quality assurance IEC 60601 FDA guidance Traceability Verification and validation Design Assurance IEC 62304 Design control Software validation +45

Senior Full Time

USD 104K+

Quality Engineer - SaMD
Remote, United States

Nonconformance evaluations External audits Medical device QMS 21 CFR Part 820 FDA CFR 21 820 Verification and validation Healthcare Software Process controls IEC 62304 +52

USD 84K+

Sr. Engineer, Device Technology (Hybrid)
USA - Pennsylvania - West Point, United States

Materials engineering Complex assembly Packaging operations Autoinjectors Drug delivery systems Device risk management Device transfer Prefilled syringes Control strategies +65

Senior Mid Full Time

USD 114K+

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

Insulet Corporation

FDA guidelines Project collaboration Traceability FDA compliance IEC 62304 Helix Software Requirements DOORS Change Orders +43

Senior Full Time

USD 109K+

Director, Technology Transfer (Device)
USA - Pennsylvania - West Point, United States

Device technology transfer Design verification testing Device technology Combination products Risk communication Scale-Up Drug product Combination product development Regulatory inspections +66

Exec Senior Full Time

USD 153K+

Associate Director, Device Technology
USA - Pennsylvania - West Point, United States

Device risk management Design verification testing Drug delivery systems Device transfer Prefilled syringes Autoinjectors Control strategies Device technology Scale-Up +70

Senior Mid Full Time

USD 139K+

Senior Staff Engineer, Design QA, Hardware and Embedded SW (Remote/Flexible)
US - Massachusetts (Acton - Office), United States

Insulet Corporation

Mixed signal circuits Custom integrated circuits Digital circuits Hardware systems Verification Plans IEC 60601 Analog circuits FDA guidance Design Assurance +37

Senior Full Time

USD 104K+

Software Design Quality Engineer
Salt Lake City Zevex, United States

IEC 62304 ISO 14971 ISO 13485 Software development lifecycle Automated Testing Computer Science Quality Assurance Regulatory Compliance Software Development +7

USD 100K+

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+

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+

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+

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