Director of Human Factors

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:

Job Description

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.

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.

Job 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 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.
• 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, presentation, and organization skills.
• Excellent organizational, technical problem solving, negotiation, and communication skills (written and verbal), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to manage external consultants.
• Works with global teams at times, availability will include working across the associated time zones.
• International and domestic travel up to 15% of the time.

Preferred:

• Master's degree in Human Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences related subject area preferred.
• Certified Professional Ergonomist (CPE) or Certified Human Factors Professional (CHFP) preferred.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

• Competitive salaries, annual bonus and 401(k)* with company match

• Comprehensive medical, dental, vision coverage effective on start date

• 24/7 Employee Assistance Program

• Free live and on-demand Wellbeing Programs

• Generous Paid Vacation and Sick Time

• Paid Parental Leave and Adoption Assistance*

• 12 Paid Holidays

• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset

• Offers onsite, hybrid and field work environments

• Paid volunteering and charitable donation/match programs

• Employee Resource Groups

• Dedicated Training Resources and Learning & Development Programs

• Paid Educational Assistance

• 
  US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefits and incentives:

The anticipated base pay range for this full-time position in this location is $162,565.00 - $243,847.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [email protected]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Research and Development