Senior Human Factors Engineer

Amgen • Cambridge, MA

4d • $129,369 - $175,029

About The Position

The Senior Human Factors Engineer leads human factors engineering and usability engineering planning, research, development, and continuous improvement for Amgen drug delivery devices. The role applies HFE/UE best practices and current regulations and guidelines in the medical device, combination product, and biopharmaceutical industries. The engineer serves as a thought leader and user advocate, collaborating with internal and external stakeholders across functions including marketing, engineering, risk, quality, safety, manufacturing, and regulatory teams. The function designs and implements human factors research to support innovative, intuitive products and safe, effective use.

Requirements

• Doctorate degree; or a master's degree and 2 years of Human Factors Engineering/Usability Engineering experience in the biomedical, pharmaceutical, or medical device field; or a bachelor's degree and 4 years of such experience; or an associate's degree and 8 years of such experience; or a high school diploma/GED and 10 years of such experience.

Nice To Haves

• Bachelor’s or master’s degree in human factors, usability engineering, psychology, industrial design, or an engineering discipline, and 5–7 years of industry experience in multifunctional, fast-paced corporate environments.
• Experience with human factors in the design and manufacture of injectable devices or non-invasive/minimally invasive drug delivery systems.
• Experience planning, coordinating, conducting, analyzing, and reporting human factors studies without vendor support.
• Experience with methodologies such as ethnographic research, interviews, contextual inquiries, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, professional analysis, task analysis, hazard analysis, risk assessment, and formative and summative studies.
• Experience working directly with users to gather and synthesize research into product concepts and to develop and evaluate features, user interfaces, and ergonomic designs.
• Experience using low- and high-fidelity prototypes to identify and eliminate potential use errors early in development.
• Experience working in development organizations, particularly virtual development environments.
• Experience with systems design, verification, and validation.
• Functional knowledge of and experience applying relevant FDA human factors guidance, regulations, and standards, including IEC 62366, AAMI HE75, EN 60601 1-6, ISO 14971, MDR, and design controls.

Responsibilities

• Partner cross-functionally with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, and commercial teams to ensure products are safe and effective for end users.
• Lead and support human factors and usability engineering activities to improve device-user interfaces, including devices, packaging, labeling, and instructions for use.
• Develop and implement a risk-prioritized, fit-for-purpose approach to human factors activities.
• Ensure human-system capabilities and limitations are reflected in system requirements and provide HFE/UE input for device design, packaging, labeling, and training requirements.
• Identify and conduct activities to improve device-user interfaces and minimize potential use errors.
• Analyze objective and subjective usability-study data to inform product design and identify and mitigate use-related risk.
• Lead the design and execution of formative and summative human factors activities, including moderation, note taking, vendor engagement, and data analysis.
• Provide human factors expertise in preparing for clinical studies and regulatory submissions, in accordance with applicable best practices, guidance, and standards.
• Create development, design-control, DHF, and DMR documentation, including protocols, task analyses, use-related risk analyses, usability technical assessments, HF validation reports, and regulatory submissions.
• Communicate regularly with internal and external partners.

Benefits

• Health and welfare plans for staff and eligible dependents
• Retirement and savings plan with company contributions
• Medical, dental, and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program, or sales-based incentive plan for field sales representatives
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible
• Career development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed