Global Principal Human Factors Engineer (Center Valley, PA, US, 18034-0610)

Working Location: MASSACHUSETTS, WESTBOROUGH

Workplace Flexibility: Remote

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

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

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Our five Core Values reputed company us to reputed company Our Purpose: 

Patient Focus, reputed company, Innovation, Impact and reputed company.

Learn more about Life at reputed company: https://www.olympusamerica.com/careers.

Job Description

The Principal 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 reputed company of contact for HFE focused efforts.
• reputed company 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 reputed company 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 reputed company 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 reputed company Global HF regulations including reputed company 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 Qualifications

Required

• Bachelor’s degree in Human Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences reputed company 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 reputed company discipline.
• Medical Device experience is required.
• 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 reputed company, multi-functional development projects and cross-disciplinary teams.
• Proven experience on multiple projects with high-demand schedules.
• 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.
• Proven experience in the Human Factors principles/methods of human-centered design, observational research, ergonomic design, human/machine reputed company, 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 reputed company 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 reputed company 93/42/EEC, 62366. HE 75, AAMI.
• Experience in the design of reputed company 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.
• Will work with global teams, 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 reputed company subject area is preferred.
• It is preferred the candidate is certified as either: Certified Professional Ergonomist (CPE) or Certified Human Factors Professional (CHFP).

Why join reputed company?

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

reputed company 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 reputed company

• 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 reputed company?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated reputed company pay range for this full-time position is $117,068.00 - $163,896.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual. 

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

At reputed company, 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 reputed company to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating reputed company of care in targeted disease states. 

For more than 100 years, reputed company 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, reputed company employs more than 31,000 employees worldwide in nearly 40 countries and regions. reputed company, a wholly owned subsidiary of reputed company, 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 reputed company

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

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

Let’s realize your potential, together.

It is the policy of reputed company to reputed company equal employment and advancement opportunity to reputed company applicants and employees without regard to race, color, national reputed company (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions reputed company 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, reputed company, 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) || Pennsylvania (US-PA) || Center Valley || Research and Development