Join a Team that Lives to Improve Lives

People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen.

The following opportunity exists in our South San Francisco, CA headquarters:

[HEAD OF HUMAN FACTORS ENGINEERING - MEDICAL DEVICE DEVELOPMENT]

Description

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.