The Opportunity

In this role, you will provide critical human factors engineering support to cross-functional project teams developing cutting-edge combination products and drug delivery devices for parenteral pharmaceutical therapeutics. You will play a pivotal role in ensuring our innovative products are safe, intuitive, and highly effective by fully accounting for the user, the environment, and the specific drug therapy.

Key Responsibilities:

• Leadproject-level human factors activities throughout the product lifecycle, including ethnographic research, requirements definition, and use-related risk analysis ($uFMEA$).

• Design, execute, and authorprotocols and summary reports for formative usability assessments and human factors design validation (summative) studies.

• Collaborateseamlessly with cross-functional teams spanning device engineering, regulatory affairs, clinical operations, quality assurance, and marketing to shape user-centric product designs.

• Develop and refinecomprehensive instructions for use (IFUs) and quick-reference training materials for clinical trials and commercial distribution.

• Translatecomplex, multi-faceted user needs into actionable engineering requirements, delivering thorough and practical solutions to complex design challenges.

• Analyzequalitative and quantitative usability study data using statistical methods to drive evidence-based design iterations.

Who You Are

You are a highly analytical, detail-oriented, and deeply empathetic professional who puts patients and users at the center of engineering. You thrive in collaborative environments where distinct perspectives are valued, and you possess a strong desire to solve complex healthcare challenges through robust scientific and human-centered design principles.

Qualifications & Experience:

• Education:A Bachelor's, Master's, or advanced degree in Human Factors Engineering, Cognitive Psychology, Industrial Engineering, Bioengineering, or a related scientific/engineering discipline.

• Experience:A minimum of 5 years of experiencein the bio-pharma industry and/or academia (including advanced studies) after receiving a Bachelors degree.

• Technical Expertise:Demonstrated proficiency in applying human factors standards and regulatory guidances (e.g., FDA Human Factors Guidances, IEC 62366, ANSI/AAMI HE75).

• Documentation Skills:Proven experience authoring highly technical documents, including usability study protocols, data analysis frameworks, and human factors engineering reports.

• Collaboration:A track record of collaborating effectively within diverse, multidisciplinary project environments and partnering successfully with external vendors.

Lets thrive together in a culture built on trust, collaboration, respect, and high performance.

Relocation benefits are available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $90,700 - $168,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.