Human Factors Principal Engineer at Astro Studios, Inc.

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 technologies to progress further, faster. Our clients adapt and transform, and together we achieve enduring results.

We are over 4,000 strategists, innovators, designers, consultants, digital experts, scientists, engineers, and technologists. And we have deep expertise in consumer and manufacturing, defence and security, energy and utilities, financial services, government and public services, health and life sciences, and transport.

Our teams operate globally from offices across the UK, Ireland, US, Nordics, and Netherlands.

As part of our continued growth, we are expanding the Human Factors Engineering team in our Boston studio. The broader Human Factors Engineering group is based in both Boston, MA and Dublin, Ireland, and is located within PA’s Design, Engineering, and Science umbrella, helping support PA’s product development offering, which provides end-to-end innovation, proof of concept, prototyping, and later stage development/product lifecycle services. Our Human Factors team works alongside a wide range of medical device and pharmaceutical companies; be it global leaders or startups.

We are a human-centered group that partners with our clients to provide expert HF consulting services, whether it’s delivering an entire usability engineering program alongside 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 often support 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, such as physical prototype development with the engineering and industrial design team, study conduct, and occasional team events.

Qualifications

What you bring

• 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.
• 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% 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.

Additional information

Benefits package at PA

• 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. This diversity stimulates a rich, creative environment – one in which our people develop, and our clients enjoy enduring results. We’re committed to recruiting, promoting and rewarding our people solely based on their ability to contribute to PA’s goals, without regard to their sex, race, disability, religion, national origin, ethnicity, sexual orientation, age or marital status.