Work Location: South San Francisco, CA
Job Title: Human Factors Engineer
Duration: 12 Months (Temporary/Contract)
Human Factors Engineer – South San Francisco, CA
Kelly Services is currently seeking a Human Factors Engineer for one of our top clients in South San Francisco, CA.
Location: Preferred - South San Francisco / Optional - Gaithersburg MD
The successful candidate will provide human factors expertise and lead human factors engineering work on device development project teams developing drug delivery devices. The Human Factors Engineer will collaborate with these cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to guide development of combination drug device products and ensure these products are safe and effective for use.
Major Duties and Responsibilities:
The candidate will be responsible for the following activities:
• Developing human factors engineering strategies and leading HF activities on drug-device combination product program teams, including ethnography, requirements definition research, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies
• Writing and reviewing HF sections for health authority submissions.
• Interacting with health authorities during face to face meetings and in written responses.
• Interacting with senior leaders with regards to HF strategy and implementation.
• Improving internal Human Factors processes to ensure consistency, compliance and efficiency
• Degree in human factors engineering, bioengineering, mechanical engineering, or related discipline. BS and a minimum of 5 years of related experience or MS and a minimum of 3 years of related experience.
• The right candidate will have 5+ years’ experience in applying Human Factors engineering to medical device or combination product development. Years of required experience will vary based on the highest level of education completed, the level of expertise within combination products and the level of position being interviewed for.
• Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidance's for medical devices and combination products
• Experience working cross-functionally on risk management activities
• Proven ability to clearly communicate how study results can be implemented into design
• Experience working with external consultancies, or as part of an external consultancy team that supported the design and development of new medical devices
• Ability to analyze data, including knowledge and proficiency with basic statistics
Other Skills and Qualifications:
• Ability to communicate effectively in writing, verbally, and as a presenter
• Demonstrated tie management, decision making, presentation, and organization skills
• Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team
• High level of initiative and ability to work independently
As a Kelly Services employee, you will have access to numerous perks, including:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay and service bonus plans
- Group-rate insurance options available immediately upon hire*
As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.