Amgen Senior Engineer - Senior Human Factors Engineer / Usability Engineer (HFE/UE) in Soborg, Denmark
The Senior Human Factors Engineer (HF/ID) will help guide human factors and industrial design activities for development of Amgen drug delivery devices/systems taking into consideration all aspects of the user, the intended use, the use environment (eco-system), and the drug therapy being delivered. The Senior Human Factors Engineer will collaborate with marketing, engineering, quality, manufacturing and regulatory team members to create innovative and intuitive-to-use products through the application of human-centered design methodologies through Usability assurance, determination of desired user profiles, and user documentation.
The Senior Human Factors Engineer will work with the Director of Human Factors to collaborate with internal and external team activities that assure brand driven aesthetics are applied consistently across the entire product portfolio. They will help with planning, execution and reporting of human factors engineering, user interface and industrial design studies across assigned device programs according to current regulations and guidelines within the medical device and bio-pharmaceutical industries, ensuring that expert HF/ID input is provided to device design teams for enforcing design requirements, packaging requirements, training requirements and use instructions, design validation activities and clinical studies in support of regulatory submissions. The Senior Human Factors Engineer ensures:
Human-system capabilities and limitations are properly reflected in the system requirements.
Human-system performance and safety risks are appropriately addressed in program baseline.
Assists in determining the human factors activities to be undertaken during the program, the schedule for conducting them, their relative priority, and the expected costs to be incurred.
Master's Degree & 3 years of Engineering or Operations experience
Bachelor's Degree & 5 years of Engineering or Operations experience
Associate's degree & 10 years of Engineering or Operations experience
High school diploma/GED & 12 years of Engineering or Operations experience
Master's degree in Human Factors, Human-Computer Interaction, Industrial Design, Cognitive Psychology, and 6+ years of business experience, working in development organizations in multiple parallel and virtual development environments
4+ years experience working in the development of electro-mechanical systems design, verification and validation
Excellent organizational, technical problem solving and communication skills (written and verbal), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to lead external design consultants
Subject matter expert of principles and industry application of Medical Device and healthcare regulations including: FDA’s Human Factors Guidances, Labeling for home use, 14971, 62366. HE 75, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, MHRA HF Guidance, FDAs Quality System Regulation (QSR), ISO 13485, EN 60601, Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers, Design Considerations for Devices Intended for Home Use, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, Draft Guidance for Industry List of Highest Priority Devices for Human Factors Review, Applying Human Factors and Usability Engineering to Medical Devices, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, General Device Labeling - 21 CFR Part 801, Use of Symbols - 21 CFR Part 801.15
HF/ID experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal)
Experience working directly with customers to gather, synthesize and convert user research into concepts that differentiate products in the market
Experience working directly with customers to develop and evaluate new product features, user interfaces and ergonomic designs, and with ensuring customer satisfaction
Knowledge of relevant human factors regulations, standards and guidance for medical devices and pharmaceutical packaging
Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines
Proven experience using low and high fidelity prototypes to identify and eliminate potential use errors early in the development process
Demonstrated time management, decision making, presentation and organization skills
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.