Principal Human Factors Engineer

Olympus Corporation of the Americas•Westborough, MA

3d•$134,629 - $188,480•Hybrid

About The Position

The Principal Human Factors Engineer will support the US R&D Team as a Human Factors expert providing project support, mentoring and guidance in Human Factors and Usability Engineering processes; managing the creation and execution of Human Factors documentation to ensure compliance with regulatory requirements in alignment with the business strategy of the company. The ideal candidate is a hands-on project and multi-disciplinary technical leader with a strong medical device background and excellent communication skills. This role of principal HFE will be needed to help review documentation, coordinate HF consultants and to collaborate on Global template creation to ensure Olympus HF activities are set up to succeed.

Requirements

Bachelor’s degree in human Factors (HF), Cognitive Psychology, or other Engineering/Lif e Sciences related subject area is a minimum requirement.
Minimum 8 years of Human Factors experience with a M.S. or 12+ years with a B.S. degree in Human Factors or other related discipline.
Medical Device experience is required.
Will work with global teams, availability will include working across the associated time zones.
International and domestic travel up to 15% of the time.

Nice To Haves

Master's degree in human Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences related subject area is preferred.
Certified Professional Ergonomist (CPE) or Certified Human Factors Professional (CHFP) preferred.
Problem Solving, Technical Aptitude, Attention to Detail, Solution Oriented, Effective Verbal and Written Communicator.

Responsibilities

Provide project and technical leadership as it relates to Human Factors in the product development process including structuring and planning HF ef forts, conducting HF activities and creating documentation.
Establish and foster strong collaborative relationships with internal team members and external partners in the execution of HF activities.
Provide expert consultation to multiple projects and multi-disciplinary design teams to execute HFE projects/studies and assume responsibility for project execution and quality.
Serve as a key point of contact for HFE focused efforts.
Develop and document HFE processes, tools, and templates for staff education and training.
Author comprehensive human factors engineering protocols and reports (e.g., Usability engineering reports) and support the design and execution of formative and summative human factor studies to address the needs of the requirements setting, design testing, and validation stages of physical and digital medical devices.
Ensure that expert HFE input is provided to product design teams and the Regulatory team for addressing design requirements, packaging requirements, IFU’s, design validation activities in support of regulatory submissions.
Partner with Quality teams in ensuring appropriate risk assessment related to usability
Ensure that human capabilities and limitations are properly reflected in the system, safety risk and user needs requirements.
Coach HFE team members through mentorship, training, and professional development
Maintain a deep understanding of all Global HF regulations including all FDA Guidance and IEC 62366.
Partner with Marketing, Design, and R&D teams in engaging end users for user needs identif ication and user input to design concepts.