Human Factors Director

Role Description

This is a full-time hybrid role for a Human Factors Director based in Westborough, MA, with the flexibility for remote work. The Human Factors Director will lead and execute user-centered design activities throughout the product development lifecycle. Responsibilities include conducting user research, usability testing, and human factors evaluations to enhance product safety and effectiveness. The director will work closely with cross-functional teams to ensure compliance with regulatory requirements and industry standards related to medical device usability and human factors engineering.

Responsibilities

⦁  Be the US HF team leader directing the team and leading work on multiple HFE projects and s
upporting the team through team meetings, project resourcing analysis and solutioning

⦁  Lead the design and execution of formative and summative human factor studies of physical and digital medical devices including instructions, packaging, and training

⦁  Be the Human Factors subject matter expert on project teams providing project support and Human Factors guidance.

⦁  Manage the execution and reporting of human factors activities including those completed by vendors.

⦁  Ensure that human capabilities and limitations are properly reflected in the system, safety risk and user needs requirements and d
rive Human Factors Engineering requirements in the design process.

⦁  Author comprehensive human factors engineering documentation including protocols and reports (e.g., Usability engineering reports)

⦁  Direct and be hands on, should projects need it

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Be the point of contact for regulatory body audits and communications for the region

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Strategically plan OSTA Projects at times with project HF team member and/or Global HF, determining required activities and level of effort, resourcing

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Identify qualified HF Vendors for the region and shepherd process for HF Vendors to become engaged in projects

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Collaborate with cross-functional leadership and Global HF to develop and communicate HFE vision and strategy as well as
with internal team members and external partners in the execution of HF activities

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Coach HFE team members through mentorship, training, and career track development

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Independently review HF work on projects to ensure best practices and compliance to regulatory body expectations and alignment with Global HF

Experience:

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Minimum years of HF experience: 8+ years with a M.S. or 12+ years with a B.S. degree in Human Factors or related discipline.

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Minimum years of leadership experience: 4+ years leading a team of HFEs

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Medical Device experience is required.

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Experience with:

• complex multi-functional development projects with high-demand schedules
• working directly with users to develop and evaluate new product features, user interfaces and ergonomic designs to track performance as it relates to usability goals
• the design of Formative and HF/Summative Validation studies to address usability requirements, context of use, validation of medical device development
• conducting user research, such as field studies and interviews, and analyzing user feedback
• writing human factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports)

Qualifications

• Expertise in human factors engineering, usability testing, and user-centered design methodologies
• Knowledge of medical device regulatory standards, including FDA and ISO requirements
• Proven track record applying Human Factors principles/methods to human-centered design, observational research, ergonomic design, human/machine interface development, and data collection/analysis.
  Proficiency in preparing usability engineering files and risk management documentation
• Strong analytical and problem-solving skills
• Excellent communication, collaboration, and leadership abilities
• Previous experience in the medical device or healthcare industry is a significant advantage