Medical Device Usability Engineer

2 weeks ago


Plymouth, United States VDart, Inc. Full time

Job Title: Medical Device Usability Engineer

Location: Plymouth, MN

Duration: Long Term Contract

Open to: C2C (Corp-to-Corp) candidates

Job Description:

As a Usability Engineer / Human Factors Engineer, you will play a crucial role in ensuring the safety, effectiveness, and user-friendliness of medical devices. You will follow established human factors engineering processes and conduct evaluations to validate new and existing medical devices, adhering to international and national regulatory standards.

Responsibilities

  • Human Factors Requirements: Collaborate with project teams to define human factors and usability requirements for new and existing medical devices.
  • User Advocacy: Represent the end-user's perspective to ensure devices are safe, effective, easy to use, and minimize user errors.
  • Regulatory Compliance: Ensure design, testing, and documentation align with relevant human factors and usability standards (ISO 62366, HE 75, etc.).
  • User Analysis: Identify intended users, use environments, and potential hazards. Develop product use cases, critical user tasks, and use specifications.
  • Usability Evaluations: Plan, execute, and report on formative and summative usability evaluations.
  • Documentation: Prepare usability reports and other documentation required for regulatory submissions.

Education:

  • Bachelor's degree in Human Factors, Industrial Design, User Experience Design, Cognitive Psychology, Biomedical Engineering, Biomechanical Engineering, or a related field.
  • Preferred: Master's degree in one of the aforementioned fields.

Experience:

  • 4-6 years of experience in human factors, usability engineering, or product design and development within the medical device industry.

Skills:

  • Strong understanding of medical device design and regulatory processes.
  • Excellent communication and writing skills.
  • Experience with medical device design and development standards (IEC 62366, IEC 62304, ISO 14971, HE 75).
  • Knowledge of system, electrical, mechanical design, and software integration.
  • Experience with complex electro-mechanical systems.
  • Familiarity with third-party service providers and external certification laboratories.
  • Proven ability to conduct and report on usability evaluations.

Additional Requirements:

  • Strong understanding of human factors engineering principles and methodologies.
  • Ability to work collaboratively in a cross-functional team environment.
  • Problem-solving and analytical skills.
  • Attention to detail and organizational skills.

VDart Group, a global leader in technology, product, and talent management, empowers businesses with comprehensive solutions through our four distinct, industry-leading business units. With a diverse team of over 4,000 professionals across 13 countries, we deliver strong results across various industries, including Fortune 500 companies.

Leveraging our deep expertise as a global provider of resources and solutions, we serve a wide range of industry verticals, including BFSI, Automotive, Healthcare, Mobility, Energy, Life Sciences, Manufacturing, Consumer Industries, and Technology.

With over 16 years of experience, VDart has evolved to meet the needs of leading technology brands, placing and training more than 20,000 professionals and shaping the industry's future.

Our continuous reinvention, providing resources for IT solutions and unique digital solutions, has positioned us as a top growth leader in digital talent management and technology consulting.

Committed to "People, Purpose, Planet," we prioritize social responsibility and sustainability, as evidenced by our EcoVadis Bronze Medal Certification and participation in the UN Global Compact.

Our dedication to delivering strong results has earned us recognition as a trusted advisor for businesses seeking to drive innovation and growth, including many Fortune 500 companies.

Join our network Partner with VDart Group to leverage our global network, industry expertise, and proven track record with a diverse clientele.


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