Job Description

Position Overview

Crux is looking for a talented Advanced Human Factors Engineer to join our growing team. Based in our Boston MA office, you will be involved in planning, running and delivering a range of exciting human factors projects across all phases of development.

You will be working with both internal project teams and global medical clients on developing safe and usable medical devices, ensuring that user needs are considered early and often throughout the design process. You will be responsible for identifying user needs and supporting use-related risk mitigation through the application of Human Factors principles and best practice.

The role involves a range of activities such as desk and field research, use-related risk management, planning and conducting Human Factors studies and compiling results into clear and concise reports appropriate for client teams and in accordance to regulatory standards.

Check out what our Human Factors team is all about: Crux - Human Factors

Principal Responsibilities

• Accurate planning and timely delivery of usability and Human Factors activities.
• Ensuring user needs are identified and met through the integration of usability in product development.
• Analyzing data to generate tangible and feasible design solutions that improve the usability and reduce use-related risk.
• Liaising with external suppliers to enable efficient execution of Human Factors studies.
• Producing clear, concise written reports and presentations.
• Formulating and executing of a design and usability strategy to meet client objectives.
• As a subject matter expert, presenting ideas to colleagues and clients with varying levels of technical knowledge, questioning where appropriate to ensure impactful output and being persuasive and able to 'sell' your ideas to others.
• Promoting awareness of usability within the business and helping to promote Cruxs growing in-house Human factors capabilities by proactively developing knowledge of relevant regulations, processes and best practice.
• Building trusted relationships within existing client accounts and pursuing opportunities and referrals for selling usability services into these accounts.
• Preparing and advising on small quotes.
• Support Cruxs continual development, improving processes and procedures.

What Were Looking For

Essential

• Experience of applying a range of Human Factors techniques and usability principles.
• In-depth understanding of Human Factors guidance documents and standards for medical device development.
• Experience in evaluating and improving designs based on sound usability understanding.
• Skilled and experienced in moderating varied user research and putting participants at ease.
• Experience in data capture and analysis.
• A proven ability to synthetise a lot of information and distil it into meaningful design recommendations.
• Strong report writing skills.
• Excellent presentation and interpersonal communication skills.
• Exceptional planning and organisational skills.
• Ability to work cooperatively and dependably as part of a team or independently.
• Great attention to detail.
• An understanding of up-to-date regulatory frameworks surrounding medical device development, including IEC62366 and FDA Human Factors regulations
• Flexible and accommodating work ethic.
• Achieved a degree in a relevant accredited degree program, ideally with GPA 3.5 and above.

Desirable

• Experience in a consultancy environment for the medical, pharma or health industries.
• Working towards CIEHF chartership.

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