Director of Human Factors

Job Description

Working

Location:

MASSACHUSETTS, WESTBOROUGH

Workplace Flexibility: Hybrid

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our

Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus:

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

This role requires a committed strategic thinker, a collaborative teammate, a mentor and hands‑on multi‑disciplinary technical leader with a strong medical device background and excellent communication skills. This position leads the US Human Factors team, helps review documentation and Human Factors consultants to ensure Olympus HF activities are set up to succeed.

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

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 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 93/42/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.
• Ex…