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
Date Posted: 01/03/2019