Head of Human Factors Engineering - Medical Device Development

South San Francisco
California, United States of America


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The Position

Head of Human Factors Engineering

The human factors engineering team collaborates with multifunctional teams including device engineering, regulatory, clinical, quality, marketing, and program management team members to inform and guide development of innovative products and ensure that those products are safe and easy to use.  This team manages human factors engineering activities within Genentech device development programs including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and final summative design validation studies.

The head of human factors engineering will work independently and will provide guidance, coaching and training to direct reports and manage work activities of staff members. The work is reviewed with a focus on long-term perspectives, as the candidate exercises considerable latitude in determining objectives and approaches to assignments, and has responsibility of effective interaction with the Health Authorities in the area of human factors.  The head will manage and grow a team of human factors engineers and scientists, responsible for the human factors engineering activities for 15-20 active projects.

The incumbent in this position will be responsible for supporting human factors engineering activities and facilitating product development towards the goal of commercialization. This objective will be accomplished by executing activities in the areas of:

Team Leadership

  • Leads a team of 5-8 human factors engineers and scientists.

  • Manage and administer all aspects of personnel performance and staff development for the group.

  • Select, hire, and train staff on company and department policies, systems, and processes.

  • Coach, develop, and retain staff by providing an environment that encourages ongoing personal and professional development.

  • Manage and ensure the setting of goals for the team and the staff, and provide regularly scheduled feedback throughout the year, including workload prioritization and balancing.

Human Factors Engineering

  • Direct the human factors engineering strategy for the Genentech combination products portfolio.

  • Develop collaborative relationships with key internal stakeholders including device engineering, pharmaceutical development, packaging, regulatory, clinical, marketing, and global product strategy.  

  • Maintain proficiency in current regulations and best practices for human factors engineering for medical devices and combination products (IEC 62366, AAMI HE75, etc) and advise senior leadership on related issues.

  • Collaborate with regulatory teams to develop human factors engineering strategies for new product regulatory filings, create regulatory submission documents, and respond to questions from regulatory agencies.

  • Represent the human factors team at internal and external conferences, committee meetings, workshops, and other external forums.

  • Manage budgeting, forecasting, and resource planning for the human factors engineering team.

  • Oversee collaborations with multiple external research partners.

Quality Systems Compliance

  • Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.

  • Use, create, and implement device development procedures and templates ensuring alignment with human factors engineering industry standards and regulatory requirements.

  • Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.

  • Draft, review and/or approve design control documents and regulatory filings to support human factors engineering activities.  


 

Qualifications

The right candidate will possess the following skills and experience:

  • 12+ years of relevant industry experience or a combination of industry experience and advanced degree in a relevant discipline.

  • Excellent communication skills.

  • Experience working with external partners.

  • Highly organized and detail oriented.

  • Experience in drafting and reviewing the human factors sections of regulatory submission documents

  • In-depth knowledge of human factors design principles and usability evaluations, including experience conducting formative and summative human factors studies.

  • 5+ years of direct supervisory experience with the demonstrated ability to build and lead strong technical teams and develop technical staff.

  • Proven track record of working effectively in a matrix organization with cross-functional teams (e.g., device development, regulatory, clinical, quality, and program management) and experience working in a highly collaborative environment.

  • Ability to effectively direct the activities of a human factors engineering group supporting multiple simultaneous complex development programs.

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Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.


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