Senior Human Factors Engineer - Thousand Oaks, CA

Company: Msccn
Location: Thousand Oaks
Posted on: April 1, 2026

Job Description:

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Engineer – Senior Human Factors Engineer / Usability Engineer (HF/ UE) What you will do Let’s do this! Let’s change the world! In this vital role you are responsible for leading HFE/UE planning, research, development, and continuous improvement of Amgen drug delivery devices using HFE/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. The Senior Human Factors / Usability Engineer is a thought leader and user advocate both within the HF groups and to external teams. You will be a key stakeholder and collaborate with internal and external partners and across functions within marketing, engineering, risk, quality, safety, manufacturing, and regulatory teams. Our function is to design and implement human factors research to drive innovative and intuitive products. You will lead project study design, methodology, data collection, root cause analysis to inform design. You will support human factors and usability engineering activities to ensure the product user interface-design of Amgen’s products support safe and effective use. Role Responsibilities: The Sr. HFE/UE responsibilities include but are not limited to: Partner cross-functionally with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, commercial to ensure Amgen products are safe and effective for end users. Lead and support human factors and usability engineering activities to improve the design of products, specifically the device-user interface. This includes the device, packaging, labeling, and instructions for use. Develop, strategize, and implement a risk-prioritized, fit-for-purpose approach to HF activities. Ensure human-system capabilities and limitations are accurately reflected in the system requirements, and HFE/UE input is provided across functions to develop device design, packaging, labeling, and training requirements. Identify, lead, and support appropriate human factors and usability engineering activities to improve the design of device-user interfaces, including the device, packaging, labeling, and instructions for use to minimize the potential for use errors. Analyze objective and subjective data from usability studies to inform product design, identify and mitigate use-risk, and provide robust solutions. Lead the design and execution of human factors formative and summative activities, including moderation, note taking, vendor engagement, and analysis of data. Support and provide HFE expertise in preparation for clinical studies and regulatory submissions in accordance with HF best practices, guidance and standards. Create documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, use-related risk analysis (URRA), usability technical assessments, HF validation reports, and regulatory submissions. Clearly and actively communicate regularly with key internal and external partners. This position requires up to 20% yearly travel mostly local and domestic. Additional Qualifications/Responsibilities What we expect of you We are all different, yet we all use our unique contributions to serve patients. The highly organized professional we seek is a problem solver and has the requisite training and experience to be an effective contributor and team members. Basic Qualifications: Doctorate OR Master’s degree and 2 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field, OR Bachelor’s degree and 4 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field, OR Associate’s degree and 8 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field, OR High school diploma / GED and 10 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field Preferred Qualifications: Bachelor’s or Master's degree in Human Factors, HFE/Usability Engineering, or other relevant HF/Engineering discipline and 5-10 years of industry experience, working in multi-functional, fast-paced corporate environments. HF experience in the design and manufacturing of injectable devices (e.g., auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive/minimally invasive drug delivery systems (e.g., pulmonary, transdermal). HFE/UE experience planning, coordinating, conducting, analyzing, reporting human factors studies without vendor support. Experience with various HF methodologies such as ethnographic research, interviews, contextual inquiries, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, HF professional analysis, task analysis, hazard analysis, risk assessment, formative and summative studies. Experience working directly with users to gather, synthesize and convert user research into concepts that differentiate products in the market, as well as to develop and evaluate new product features, user interfaces and ergonomic designs. Experience using low and high fidelity prototypes to identify and eliminate potential use errors early in the development process. Experience working in development organizations, particularly virtual development environments. Experience working within the development of systems design, verification, and validation. Functional knowledge and experience in the practical application of relevant FDA human factors guidance, regulations and standards, including IEC 62366, AAMI HE75, EN 60601, ISO 14971, MDR, and design controls. Salary Range 135,876.00 USD - 171,000.00 USD

Keywords: Msccn, Lompoc , Senior Human Factors Engineer - Thousand Oaks, CA, Engineering , Thousand Oaks, California