Principal Engineer (Human Factors) - Hybrid

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK
Workplace Flexibility: Hybrid
Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.
Our Purpose is to make people's lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity - Empathy - Agility - Unity - Long-Term View
We deliver on our purpose and our core values by staying True to Life.
Job Description
The Principle Human Factors Engineer will support the Executive Director of Global Human Factors as a Human Factors expert providing applicable training, mentoring and guidance in Human Factors and Usability Engineering processes across the Global organization; 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
Job Duties

• Provide project and technical leadership as it relates to Human Factors in the product development process including structuring and planning HF efforts, 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 identification and user input to design concepts.

Job Qualification
Required:

• Master's degree in human Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences related subject area is preferred.
• 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.
• Medical Device experience is required.

Preferred:

• It is preferred the candidate is certified as either: Certified Professional Ergonomist (CPE) or Certified Human Factors Professional (CHFP).
• Strong background developing and validating user requirements.
• Experience with complex, multi-functional development projects and cross-disciplinary teams.
• Proven experience on multiple projects with high-demand schedules.
• Proven experience in the Human Factors principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/analysis.
• Experience working directly with users to gather, synthesize and convert user research into robust set of user needs.
• 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.
• 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 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).

Why join Olympus?
Here, people matter-our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive Medical, Dental, Visions coverage effective on start date
• 24/7 Employee Assistance Program
• Free virtual live and on-demand wellness classes
• Work-life balance supportive culture with hybrid and remote roles
• 12 Paid Holidays
• Educational Assistance
• Parental Leave and Adoption Assistance
• Volunteering and charitable donation match programs
• Diversity & Inclusion Programs including Colleague Affinity Networks
• On-Site Child Daycare, Café, Fitness Center**

*US Only
**Limited locations
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position working at this location is $131,345.00 - $183,883.00 / 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.
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
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 www.olympusamerica.com.
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
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