FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Human Factors Engineering and Usability Engineering within the Biomedical, Pharmaceutical, and Medical Device fields, with a strong focus on risk analysis, usability studies, and regulatory submissions. Proven ability to lead cross-functional collaboration and communicate effectively with internal and external partners.
Highest-signal resume keywords
Human Factors Engineering ExperienceUsability Engineering ExperienceRegulatory Submission PreparationUsability Study AnalysisCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Human Factors EngineeringUsability EngineeringRisk AnalysisUsability Study DesignTask AnalysisUse-Related Risk AnalysisUsability Technical AssessmentHF Validation ReportsClinical Study ProtocolsData Analysis
Soft Skills
Strong Communication SkillsCross-Functional Collaboration
Industry Keywords
Biomedical FieldPharmaceutical FieldMedical Device FieldHFE Best PracticesUsability StandardsRegulatory Guidelines
About the role
Key responsibilities & impact- Lead HFE/UE planning, research, development, and continuous improvement of Amgen drug delivery devices
- Partner with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, and commercial functions
- Lead and support human factors and usability engineering activities for device-user interfaces, packaging, labeling, and instructions for use
- Develop and implement a risk-prioritized, fit-for-purpose approach to HF activities
- Ensure human-system capabilities and limitations are reflected in system requirements
- Analyze objective and subjective usability-study data to inform product design and mitigate use risk
- Lead formative and summative human factors activities, including moderation, note taking, vendor engagement, and data analysis
- Provide HFE expertise for clinical studies and regulatory submissions
- Create documentation supporting development activities, design controls, DHF, DMR, and regulatory submissions
- Communicate regularly with key internal and external partners
Requirements
What you’ll need- Doctorate degree 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
- Experience with Human Factors Engineering/Usability Engineering in biomedical, pharmaceutical, or medical device fields
- Ability to lead HFE/UE planning, research, development, and continuous improvement
- Knowledge of HFE/UE best practices, current regulations, guidelines, and standards
- Experience with human factors formative and summative activities, including moderation, note taking, vendor engagement, and data analysis
- Experience with usability studies, root cause analysis, and use-risk mitigation
- Ability to prepare clinical study and regulatory submission materials
- Experience creating protocols, task analysis, use-related risk analysis (URRA), usability technical assessments, HF validation reports, and regulatory submissions
- Strong cross-functional collaboration and communication skills
- Ability to travel up to 20% yearly, mostly local and domestic
- Sponsorship for this role is not guaranteed
Benefits
Comp & perks- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Work/life balance support
- Up to 20% yearly travel, mostly local and domestic