Sr Human Factors Engineer I
Gilead Sciences
2 months ago
Remote friendly (San Francisco Bay Area)
United States
$136,340 - $176,440 USD yearly
Operations
Sr. Human Factors Engineer I
Qualified candidates will focus on the development of devices and drug-device combination products such as pre-filled syringes and auto-injectors.
Specific Job Responsibilities
- Lead or support human factors engineering (HFE) strategies and HFE activities for device combination product design and development from feasibility, clinical development, through registration, and post-market (requirements definition, use-related risk analysis, formative usability studies, instruction/training development, summative usability studies).
- Author HFE deliverables for device design history files and HFE sections for health authority submissions and written responses.
- Educate team members and internal stakeholders on the HFE development process and approach.
- Interface and coordinate with HFE consulting firms to execute human factors engineering activities.
- Improve internal HFE processes for consistency, compliance, and efficiency.
- Ensure all HFE work is performed in accordance with SOPs and applicable regulatory requirements.
Required Education
- B.S. in mechanical engineering, chemical engineering, bioengineering, or related scientific field with 6+ years of relevant experience
OR
- M.S. in mechanical engineering, chemical engineering, bioengineering, or related scientific field with 4+ years of relevant experience
Experience & Skills
- Experience leading HFE efforts for combination product development and commercialization; working knowledge of human factors, design controls, and risk management regulations/standards/guidance for medical devices and combination products.
- Excellent verbal, written, and interpersonal communication skills.
- Ability to facilitate interfaces with medical device vendors and HF consulting firms.
- Ability to analyze data and identify relevant design updates.
- Ability to write clear, concise, high-quality documents.
- Ability to exercise judgment in ambiguous situations and follow procedures/policies.
- Experience managing project timeline expectations for HFE activities.
- Deep knowledge of regulatory/compliance requirements for HFE and combination product risk management.
- Ability to collaborate with cross-functional teams and influence stakeholders.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.
Benefits (if part of the posting)
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.
Qualified candidates will focus on the development of devices and drug-device combination products such as pre-filled syringes and auto-injectors.
Specific Job Responsibilities
- Lead or support human factors engineering (HFE) strategies and HFE activities for device combination product design and development from feasibility, clinical development, through registration, and post-market (requirements definition, use-related risk analysis, formative usability studies, instruction/training development, summative usability studies).
- Author HFE deliverables for device design history files and HFE sections for health authority submissions and written responses.
- Educate team members and internal stakeholders on the HFE development process and approach.
- Interface and coordinate with HFE consulting firms to execute human factors engineering activities.
- Improve internal HFE processes for consistency, compliance, and efficiency.
- Ensure all HFE work is performed in accordance with SOPs and applicable regulatory requirements.
Required Education
- B.S. in mechanical engineering, chemical engineering, bioengineering, or related scientific field with 6+ years of relevant experience
OR
- M.S. in mechanical engineering, chemical engineering, bioengineering, or related scientific field with 4+ years of relevant experience
Experience & Skills
- Experience leading HFE efforts for combination product development and commercialization; working knowledge of human factors, design controls, and risk management regulations/standards/guidance for medical devices and combination products.
- Excellent verbal, written, and interpersonal communication skills.
- Ability to facilitate interfaces with medical device vendors and HF consulting firms.
- Ability to analyze data and identify relevant design updates.
- Ability to write clear, concise, high-quality documents.
- Ability to exercise judgment in ambiguous situations and follow procedures/policies.
- Experience managing project timeline expectations for HFE activities.
- Deep knowledge of regulatory/compliance requirements for HFE and combination product risk management.
- Ability to collaborate with cross-functional teams and influence stakeholders.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.
Benefits (if part of the posting)
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.