Senior Human Factors Engineer

Olympus Corporation; Boston (MA); Híbrido; USD 100.000 - 135.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary and bonus

401(k) with company match

Medical, dental, vision coverage

Paid time off and holidays

Descripción de la vacante

Olympus Corporation in Westborough, MA is seeking a Senior Level Human Factors Engineer to lead Human Factors and Usability activities ensuring safety and regulatory compliance for medical devices. You will guide user-centered design from ideation through development, collaborating with design, regulatory, and clinical teams in a hybrid work setting.

The role requires extensive HF expertise, medical device experience, and strong leadership to mentor team members while advancing product usability

Formación

• Bachelor’s degree in HF, Cognitive Psychology, or related field.
• Minimum 5 years HF experience with BS or 4 years with MS.
• Medical device experience.
• Strong prioritization and multitasking.
• Knowledge of FDA, IEC, AAMI/ANSI requirements.

Responsabilidades

• Act as HF subject matter expert providing technical leadership for product development and sustaining efforts.
• Lead multiple HF activities and ensure project execution and quality across sites.
• Provide expert HF input for design requirements for physical and digital devices, labeling and instructions.
• Generate HF documentation compliant with FDA, IEC 62366 and internal SOPs.
• Ensure HF deliverables reflect user needs and system safety considerations.
• Develop comprehensive HF/UE reports and risk analyses and support Design Validation as needed.
• Communicate HF strategies to Core Team and leadership with high quality deliverables.
• Mentor team members and vendors in HF practices and processes.
• Coordinate with Marketing and clinicians to understand procedures and environment for design decisions.
• Travel as needed up to 15% and collaborate across global teams.

Conocimientos

Human Factors

Regulatory compliance

Risk analysis

Design Controls

Technical communication

Educación

Bachelor’s degree in HF or related field

Master’s degree in HF or related

Descripción del empleo

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: https://www.olympusamerica.com/careers .

Job Description

This role will support new product development teams and sustaining teams as a Senior Level Human Factors Engineer, leading 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 provide subject matter guidance to 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

• As Human Factors subject matter expert, provides technical leadership and Human Factors guidance for product development and/or sustaining efforts across multiple sites
• Support multiple product development and/or sustaining projects and assume responsibility for project execution and quality.
• Provide expert HFE input for design requirements for physical and digital medical devices, packaging requirements, labelling and instructional materials.
• Understand HF regulatory expectations of FDA and IEC 62366 and generate applicable documentation in compliance with both standards and internal processes (e.g. SOPs).
• Ensure that human-system capabilities and limitations are properly reflected in the system, safety risk and user needs requirements.
• Complete 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. Assist Design Validation activities if needed.
• Envisions, collaborates/communicates, and documents detailed HF & Usability strategies while mindful of the interests of all Core Team Members.
• Provides technical updates to R&D manager, and/or to an R&D Core Team Member, through weekly discussions and monthly updates.
• Communicates with Core Team and Extended Team Members, while ensuring all HF deliverables are completed with a high degree of quality, and attention to detail.
• Prioritizes and organizes work/efforts based on project priorities.
• Collaborates on the development of the technical development schedule and monitors advancement in collaboration with the Project Manager. Reports advancement to Core Team and to R&D Leadership.
• Completes use related risk analysis and coordinates collaboration with other contributors on this as needed.
• Consults with the Marketing core team member and clinicians to ensure a thorough understanding of the procedure, products use, and environmental factors to ensure appropriate design decisions.
• Manages, supports, coaches and mentors other team members in Human Factor practices and processes as well as vendors involved in the completion of Human Factors & Usability Efforts
• Manages the execution and reporting of human factors evaluations.
• Supports internal and external 3rd part audits as a Human Factors expert.
• Coach and mentor others in Human Factors practices and processes.

Job Qualifications

Required:

• Bachelor’s degree in Human Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences related subject area.
• Minimum of 5 years of HF experience with a BS Engineering degree or Minimum of 4 years with an MS degree in Human Factors or other related discipline.
• Medical Device experience.
• Well organized, flexible self-starter with the ability to work independently, but also effectively on teams. Excellent at prioritization and multitasking.
• Deep working knowledge of Human Factors in medical device development, Design Controls, and Use Related Risk practices, requirements, and standards including FDA, IEC, and AAMI/ANSI.
• Effective verbal and written communication skills, particularly in moderating usability studies.
• Ability to work collaboratively on cross-functional teams.
• Strong technical skills including: Problem-solving. VOC translation to Design Specs. Human Factors processes. Managing usability studies (i.e. Formative and Summative). Use Risk Management. Experimental Design.
• Demonstrated willingness to travel as needed to support user research, clinical observations, formative evaluations, validation studies, customer engagement, and collaboration across global development sites.
• Problem Solving, Technical Aptitude, Attention to Detail, Solution Oriented, Effective Verbal and Written Communicator.
• Will work with global teams at times, availability will include working across the associated time zones on occasion.
• Domestic and/or international 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.
• Certified Professional Ergonomist (CPE) or Certified Human Factors Professional (CHFP) certification.

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: https://www.olympusamerica.com/careers/benefits-perks .
The anticipated base pay range for this full-time position in this location is $100,263.00 - $135,355.00 / 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 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 [e-mail]. 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