Director of Human Factors

Director of Human Factors

Olympus Corporation

Working Location

Massachusetts, Westborough

Workplace Flexibility

Hybrid

Job Description

This role supports the US R&D Team as both a leader of the OSTA HF team and 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.

Job Duties

• Be the OSTA HF team leader and SME for initiatives and queries from leadership, other disciplines.

• Direct and lead multiple HFE projects or phases at any one given time, leading the design and execution of formative and summative human factor studies of physical and digital medical devices.

• Direct and be hands on, should projects need it.

• Be the point of contact for regulatory body audits and communications for the region.

• Strategically plan OSTA projects at times with project HF team member, determining required activities and level of effort, resourcing.

• Identify qualified HF vendors for the region and shepherd process for HF vendors to become engaged in projects.

• Ensure that human-system capabilities and limitations are properly reflected in the system, safety risk and user needs requirements.

• Ensure that expert HFE input is provided to product design teams for addressing design requirements, packaging requirements, IFU’s, etc in support of regulatory submissions.

• Collaborate with cross‑functional leadership to develop and communicate a HFE practice vision and strategy.

• Establish and foster strong collaborative relationships with internal team members and external partners in the execution of HF activities.

• Support regional HF team through team meetings, project resourcing analysis and solutioning.

• Coach HFE team members through mentorship, training, and career track development.

• Independently review HF work on projects to ensure best practices and compliance to regulatory body expectations.

• Determine regional budget needs.

Qualifications

Required

• Bachelor’s degree in Human Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences related subject area is a minimum requirement.

• Minimum years of HF experience: 8 years with a M.S. or 12 years with a B.S. degree in Human Factors or other related discipline.

• Minimum years of leadership experience: 4 years.

• Medical Device experience is required.

• Proven experience in the Human Factors principles/methods of human‑centered design, observational research, ergonomic design, human/machine interface, and data collection/analysis.

• Thorough knowledge and expert understanding of the principles, standards and guidance for Human Factors in Medical Device and healthcare regulations including the FDA 2016 Guidance, ‘Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff’, the FDA 2022 Guidance, ‘Content of Human Factors Information in Medical Device Marketing Submissions Draft Guidance for Industry and Food and Drug Administration Staff’, Quality System Regulation (QSR), ISO 13485, 14971, EN 60601, Council Directive

EEC, 62366. HE 75, AAMI.

• Experience on multiple projects with high‑demand schedules and with complex, multi‑functional development projects and cross‑disciplinary teams.

• Experience leading a team of HFEs.

• Experience working directly with users to develop and evaluate new product features, user interfaces and ergonomic designs to track performance as it relates to usability goals.

• Experience in the design of formative and summative human factor studies to address usability requirements, context of use, verification and validation stages of medical device development.

• Experience writing human factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports).

• Problem Solving, Technical Aptitude, Attention to Detail, Solution Oriented, Effective Verbal and Written Communicator, Leadership, Strategic Thinking, Collaborative.

• Demonstrated time management, decision making,…