Human Factors Engineer - II
Working Location: MASSACHUSETTS, WESTBOROUGH
Workplace Flexibility: Onsite
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 will support new product development teams and sustaining teams as a Human Factors Engineer, providing input in Human Factors and Usability Engineering activities and documentation required to create commercially successful, safe and usable medical products in line with regulatory compliance. The role will contribute to usability risk management, will ensure the user and context of use inform product design and will advocate for the user from ideation and down selection to design and development and implementation of medical devices.
Job Duties
- Support technical HFE activities across one or multiple projects and assume responsibility for HF documentation quality.
- Ensure that human-system capabilities and limitations are properly reflected in the system, use related safety risk and user needs requirements.
- Coordinate, conduct, and report on a range of formative usability studies during development and HF/Summative validation studies for physical and digital medical devices. Assist Design Validation activities.
- Provide HFE input for design requirements, packaging requirements, IFU’s, design validation activities and in support of regulatory submissions.
- Assist in the completion of comprehensive human factors documentation including HF Plans, Known Use Problem Reports, Task Analyses, Use Specifications, Use-Related Risk Analyses, Formative and HF/Summative Validation study documentation including Protocols and Reports, Root cause analysis, where applicable, and Comprehensive HFE/UE Reports including Residual Risk Analysis.
- Learn the landscape of HF regulatory expectations of FDA and IEC 62366 and generate applicable documentation in compliance with both standards and internal processes (e.g. SOPs). Act as a subject matter expert to multi-disciplinary teams.
- Learn Human Factors practices and processes to improve skills and provide awareness across the organization.
Job Qualifications
Required:
- BS degree or equivalent in an engineering, human factors / usability engineering, psychology or life science discipline. MS or other advanced degree desired.
- Minimum of 1-2 yrs professional experience or equivalent training/education in Human factors or related discipline and a working knowledge in product development medical device human factors and regulatory expectations.
- Minimum 1-2 yrs of experience in applying knowledge and understanding of Human Factors, User Research and Usability techniques to user interface design & usability evaluation.
- Minimum 1-2 yrs of experience with the tools and techniques required to apply Human Factors principles and Usability Engineering to products in medical device development.
Preferred:
- Awareness of Design Controls, Human Factors Engineering and Use Related Risk practices, requirements & standards in accordance with FDA and IEC.
- Able to apply knowledge and understanding of Human Factors, User Research and Usability techniques to user interface design & usability evaluation.
- Competent in the tools and techniques required to apply Human Factors principles and Usability Engineering to products in medical device development.
- Other Considerations (travel/hours availability, etc.): Travel up to 25%.
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:
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Competitive salaries, annual bonus and 401(k)* with company match
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Comprehensive medical, dental, vision coverage effective on start date
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24/7 Employee Assistance Program
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Free live and on-demand Wellbeing Programs
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Generous Paid Vacation and Sick Time
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Paid Parental Leave and Adoption Assistance*
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12 Paid Holidays
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On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:
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Work-life integrated culture that supports an employee centric mindset
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Offers onsite, hybrid and field work environments
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Paid volunteering and charitable donation/match programs
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Employee Resource Groups
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Dedicated Training Resources and Learning & Development Programs
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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 benefit and incentives.
The anticipated base pay range for this full-time position working at this location is $81,039.00 - $109,402.00 / 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 www.olympusamerica.com.
You Belong at Olympus
We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.
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 OCAAccommodations@olympus.com. 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
Nearest Major Market: Worcester
Job Segment:
Medical Device Engineer, R&D Engineer, User Experience, Engineer, Engineering, Technology