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Medical Device Design Quality Engineer

Conflux Systems, Inc.

Newton, MA

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JOB DETAILS
SALARY
$65
SKILLS
Analysis Skills, Biology, Biomedical Engineering, Code of Federal Regulations, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Electrical Components, Electricity, Electromechanics, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Hardware-Software Integration, Healthcare Quality, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Maintain Compliance, Medical Equipment, Minitab, Product Management, Quality Engineering, Quality System Requirements (QSR), Regulations, Risk Analysis, Risk Management, Root Cause Analysis, Safety Compliance, Statistics, Team Lead/Manager, Technical Writing, Technical/Engineering Design, Time Management, Traceability, Validation Testing, Writing Skills
LOCATION
Newton, MA
POSTED
30+ days ago
No C2C / Only W2 / No Sponsership
Seeking an experienced Senior Design Quality Engineer to support development of complex robotic and electromechanical Class III medical systems. This role leads Design Controls, risk management, and V&V quality oversight to ensure regulatory compliance and robust product realization across the lifecycle.

Responsibilities:

  • Serve as Quality representative and Design Controls lead on cross-functional teams.

  • Ensure compliance with FDA QSR (21 CFR 820.30), ISO 13485, MDR/MDD, and global regulations.

  • Lead risk management per ISO 14971, including system-level risk analysis, FMEA/SWFMEA, and residual risk evaluation.

  • Maintain end-to-end traceability between design inputs/outputs, risk controls, and verification & validation (V&V).

  • Review/approve V&V protocols and reports; support tolerance, worst-case, and margin analyses.

  • Support IEC 60601-1, IEC 60601-1-2, IEC 80601-2-77 electrical safety/EMC compliance.

  • Collaborate on HW/SW integration and ensure compliance with IEC 62304/82304.

  • Support supplier qualification, design transfer, and DHF completeness.

  • Contribute to IDE, De Novo, PMA submissions.

  • Lead CAPA, NCMR, complaint investigations, and root cause analysis.

Qualifications:

  • Bachelor’s degree in Engineering, Biomedical Engineering, or Life Sciences.

  • 7–10 years’ experience in Design Quality within medical devices (Class III preferred).

  • Strong knowledge of Design Controls, QSR, ISO 13485, ISO 14971.

  • Experience with Minitab or statistical analysis tools.

  • Familiarity with ESD controls, electrical components handling.

  • Strong technical writing, communication, and time management skills.
 

About the Company

C

Conflux Systems, Inc.

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