Job Description

Company description

We believe in the power of ingenuity to build a positive human future.

As strategies, technologies and innovation collide, we create opportunity from complexity.

Our diverse teams of experts combine innovative thinking and breakthrough use of technologies to progress further, faster. Our clients adapt and transform, and together we achieve enduring results.

An innovation and transformation consultancy, we are over 4000 specialists in consumer and manufacturing, defence and security, energy and utilities, financial services, government and public services, health and life sciences, and transport. Our people are strategists, innovators, designers, consultants, digital experts, scientists, engineers and technologists.

We operate globally from offices across the UK, US, Netherlands and Nordics.

PA. Bringing Ingenuity to Life.

Job description

We are expanding our Human Factors Engineering team in our Boston studio and are looking for a motivated and curious Human Factors Engineer to join our dynamic group. You will work alongside a talented team of professionals within the broader Human Factors Engineering group, which operates across our Boston, Cambridge UK, and Dublin offices. We support a wide range of medical device, biotech, and pharmaceutical companies, collaborating with both large industry leaders and exciting startups. This is a great opportunity to grow your career and gain hands-on experience in human-centered design and usability engineering within the medical technology and healthcare space.

We are a human-centered group that partners with our clients to provide expert Human factors Engineering services, whether it's delivering an entire usability engineering program as part of our multi-disciplinary device development teams, guiding clients on HF regulatory strategy, providing HF advisory support to our in-house teams, or conducting generative, formative, validation, and comparison studies. We are part of PA's product development efforts where we collaborate with designers, engineers, and scientists to ensure products meet users' needs, from concept generation through launch.

You will be joining a highly skilled and friendly team that promotes autonomy, trust, flexibility, and support for your career growth and development, in line with your goals. 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.

Key Responsibilities

• Collaborate with senior Human Factors Engineers to support usability engineering efforts for the development of medical devices and combination products.

• Contribute to human-centered design and development activities for regulated medical products

• Assist in planning and conducting usability studies (formative and validation), including moderating user research, analyzing results, and drafting reports.

• Contribute to the creation of usability engineering documentation such as use specifications, user interface specifications, and risk analysis documents (e.g., Use-FMEA).

• Learn and apply human factors principles and medical device regulations (such as IEC 62366, FDA guidance, and ISO 14971) under the guidance of senior team members.

• Support HF validation testing, providing input into test protocols and assisting with data collection, data analysis and reporting.

• Assist with tasks related to risk management, including conducting task analyses and identifying use-related risks.

• Present study results and project updates to clients and internal teams, both verbally and visually, in a clear and concise manner.

• Participate in occasional travel to client sites and/or research facility locations (typically 20-25% of the time).

Qualifications

What You Bring

• 0-1 years of industry and/or consulting working experience
• Bachelor's, MS, or PhD in Human Factors Engineering, HCI, Behavior Sciences, Experimental Psychology, Cognitive Science, Computer Science, or a related field.
• Demonstrated knowledge and application of relevant HF standards and guidance for medical devices and combination products (e.g., IEC 62366 and FDA guidance)
• Experience applying usability engineering processes to medical device development, including:
• Contributing to the multi-disciplinary human-centered design process with design input, user needs capture, and requirements definition
• 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.
• A desire for a hands-on human factors position involving study conduct and a willingness to travel domestically and internationally when needed [NOTE: travel varies based on project needs; typical travel for this role is approximately 20-25% of the year.]
• The ability to present complex data in a compelling and concise manner verbally and visually.
• We welcome individuals with a background in other (non-healthcare) sectors if they demonstrate a strong willingness and ability to learn and adapt to new regulations, standards, and technical domain knowledge.

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.

Why Join Us?

• Career Growth: We offer mentorship and support as you develop your skills in Human Factors Engineering, and provide opportunities for career advancement.

• Collaborative Environment: Work in a supportive and dynamic team where you can learn from experienced practitioners and contribute to meaningful projects.

• Flexibility: Enjoy a flexible work environment with the option to work from home much of the time, while still engaging with your team and clients in person as needed.

• Impactful Work: Contribute to improving the design and usability of medical products that make a difference in people's lives.

Additional information

Flexible Hybrid Working Schedule (Boston, MA)

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