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Human Factors Engineer

Location : Ramsey NJ US 07446
Job Type : Temp/Contract
Reference Code : 19648-BZ1
Compensation : open
Hours : Full Time
Required Years of Experience : 3
Required Education : MS or PhD in Human Factors, Systems, Biomedical, Software, Mechanical or Electrical Engineering
Travel : No
Relocation : No
Job Industry : Engineering

Job Description :

  • Contract position for a Human Factors Engineer who will contribute to usability and human factors improvements of complex electro-mechanical software driven medical devices.

  • Lead and participate in cross-functional teams that focus on usability engineering, risk management and verification and validation.

  • Ensure that remediation improvement activities are compliant with internal development processes and regulatory requirements, specifically 21 CFR 820.30.

  • Develop and maintain Use Specifications of Class II medical devices with special controls.

  • Support Systems Engineering and Marketing to develop usability-related requirements.

  • Collaborate with Systems Engineering in identifying intended users and use environments to determine potential use-related hazards.

  • Develop and maintain Risk Management documentation, including plans, hazard analysis, user failure mode and effects analysis (UFMEA), and reports.

  • Review and analyze post-market surveillance data to identify potential usability related issues.

  • Support formative and summative usability testing with internal and external stakeholders.

Required Qualifications :

  • MS or PhD in Human Factors, Systems, Biomedical, Software, Mechanical or Electrical Engineering with 3+ years of related experience.

  • Knowledge of medical device usability and human factors, including IEC 62366 and AAMI HE 75.

  • Knowledge of medical device risk management, including ISO 14971:2012.

  • Knowledge of requirements engineering.

  • Medical Device experience including thorough understanding of Design Controls (21 CFR 820.30).

  • Working knowledge of FDA and International Standards requirements as related to capital equipment

  • Experience with Requirements Management Tools (such as CaliberRM).

  • Experience with updates to legacy usability engineering files and/or user interfaces of unknown provenance.

  • Familiarity with ISO 9421 and ISO/TR 16982:2002.

Contact: Bill Zukowsky

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Date Posted: 01/03/2019



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