Senior Human Factors Engineer

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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 ofpatient 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.

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.

• 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.

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…