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Design Controls Remote Jobs

13 fresh jobs found

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+

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

Insulet Corporation

Helix alm Requirements writing Polarion alm Communication technology 21 CFR Part 820.30 Change Orders FDA guidelines Traceability DOORS +45

Senior Full Time

USD 99K+

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+

Neuro MR Development Scientist
Remote, United States

Image Reconstruction New product introduction Design Controls Clinical Solutions Keras MRI Medical Imaging Biomedical Engineering TensorFlow +30

USD 126K+

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+

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+

Director Central Quality Audit
Remote, United States

Production Controls CSQE CQA FDA CFR 21 820 CQE Product Quality Improvement Software as a medical device Medical device standards Process controls +53

Exec Senior Full Time

USD 139K+

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+

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 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+

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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