Senior Human Factors Engineer

Jobtailor; Boston (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Jobtailor is seeking a seasoned Human Factors Engineer to lead usability efforts across programs from concept through post-market support. You will gain deep knowledge of use environments through field interactions and shape user type understandings with direct engagement.

Ideal candidates bring strong experience in medical device development within regulated contexts, and demonstrate ability to negotiate with stakeholders while contributing to risk management documentation.

Qualifications

• Experience with human factors engineering process (research, planning, risk assessment, regulatory submissions).
• Experience in medical device product development in regulated environments.
• Clinical or software GUI development experience a plus.
• Ability to travel up to 20% domestically and internationally.
• Fluent in English; German and French are a plus.

Responsibilities

• Lead human factors efforts for programs from concept through post market support.
• Develop understanding of intended use environments from field exposure and user interactions.
• Tackle diverse problems impacting the broader program with method selection for evaluations.
• Represent the voice of the customer from a human factors perspective in new product development.

Skills

Human Factors Engineering

Regulatory Submissions

Usability Testing

Stakeholder Negotiation

Cross-functional Collaboration

Education

Bachelor's Degree in Human Factors Engineering

Job description

Responsibilities

• Lead human factors efforts for programs from concept through post market support, supporting and influencing usability activities for product lines and programs with minimal oversight
• Develop an understanding of intended use environments gained through time spent in the field, with a good understanding of intended user types formed through interactions with users
• Require work on problems of diverse scope that impact the broader program team and business, and contributes to projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for evaluations
• Network with key contacts outside own area of expertise, contributes information to cross functional decisions; understands importance of alignment and negotiation, representing the voice of the customer from a human factors and technical application perspective for new product development

Qualifications

• University/Bachelor's Degree in Human Factors Engineering (HFE), or Usability Engineering
• 4 to 6 years work experience in human factors/usability engineering experience/use case validation testing or equivalent experience in product development and customer interactions is required.
• Demonstrated ability with the human factors engineering process, including research, planning, risk assessment, and regulatory submissions
• Medical Device product development or experience working in a highly regulated industry is a strong plus.
• Clinical experience and/or professional experience/degrees in software development and/or GUI development is a strong plus
• Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for edits or new entries to risk management documentation
• Ability in planning, executing, documenting, and reporting usability testing, including moderation of studies
• Knowledge of the IEC 62366 standard and the FDA guidance on human factors engineering
• Good knowledge of the ISO 14971 and IEC 62304 are a plus
• Fluent in English.
• German and French are an advantage
• Ability to travel up to 20%, domestic and international is required

Core Competencies

Demonstrates expertise in Human Factors Engineering and Usability Engineering, with a strong focus on user interaction, usability testing, and regulatory compliance in product development. Proficient in stakeholder negotiation and cross-functional collaboration to ensure alignment with customer needs and technical applications.