Working Location: Massachusetts, Westborough Workplace Flexibility: HybridJob DescriptionThis 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 QualificationsRequired:- 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.
