Human Factors Principal Engineer

7 days ago


Étreux, Hauts-de-France, United States Astro Studios, Inc. Full time
Job Description

We are seeking a highly skilled Human Factors Principal Engineer to join our team in Boston, MA. As a key member of our Human Factors Engineering group, you will play a critical role in ensuring that our products meet the needs of our users.

About Us

Astro Studios, Inc. is a global leader in innovation and design. We believe in the power of ingenuity to build a positive human future. Our diverse teams of experts combine innovative thinking and breakthrough technologies to progress further, faster.

Your Role

In this hands-on position, you will work closely with our clients to deliver expert Human Factors consulting services. This includes guiding clients on Human Factors regulatory strategy, providing advisory support to our in-house teams, and conducting generative, formative, validation, and comparison studies.

You will be joining a highly skilled and friendly team that promotes autonomy, trust, flexibility, and support for your career growth and development. The majority of the role can be completed from home, but travel to the office, client, or research site will be required for certain projects.

Requirements

  • At least 3-5 years of consulting and/or industry experience (Senior HFE) or 6+ years of experience (Principal HFE)
  • Bachelor's, MS, or PhD in Human Factors Engineering, HCI, Behavior Sciences, Experimental Psychology, Cognitive Science, Computer Science, Industrial Design, Systems Engineering, Biomedical Engineering or a related field.
  • Demonstrated knowledge and application of relevant HF standards and guidance for medical devices, combination products, and health IT (e.g., IEC 62366 and FDA guidance)
  • Experience applying usability engineering processes to medical device development, including:
  • Usability Engineering file development (e.g., use specifications, expert reviews, user interface specifications, known use problem analysis, HFE summary report)
  • Understanding of use-related risk activities, such as task analyses and Use-FMEA.
  • Formative and summative (HF validation) study planning, moderating, observation, analysis, and reporting.
  • Project management and/or project leadership experience.

Nice-to-Haves

  • An understanding of the medical device development process overall, including design controls and verification and validation.
  • Familiarity with ISO 14971 and risk management processes.

Benefits Package

  • $125,000 - $175,000 per year, depending on experience
  • Group medical insurance
  • Health Savings Account with company match
  • Teladoc and informed Nurse line resources
  • Long term care plan
  • Vision plan
  • 401(k) Savings Plan with company profit sharing contribution
  • Commuter and Parking tax-savings benefit
  • 15 days paid vacation days with the opportunity to buy five additional days
  • Company and Voluntary income protection benefits
  • Gym and health incentive reimbursement
  • Pet and legal insurance Plans
  • Employee Assistance Plan
  • Annual performance-based bonus

We believe that diversity makes us a stronger firm and look to employ people with different ideas, styles and skillsets.



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