2 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. This range is provided by Aditi Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $60.00/hr - $70.00/hr Payrate: $60.00 - $70.00/hr. Summary: Company is seeking a results-driven and experienced Human Factors / Usability Engineer (HF/UE) contractor to support the Human Factors Engineering (HFE) team within the broader Combination Product Optimization (CPO) function. This role is critical in ensuring our drug delivery systems and combination products meet the highest standards of usability, safety, and regulatory compliance. This individual contributor will play a hands-on role across the product lifecycle, from early-stage user research through design input, usability testing, and preparation for FDA and global regulatory submissions. The ideal candidate will thrive in a fast-paced, matrixed environment and bring deep domain expertise in medical devices, combination products, and FDA-regulated usability engineering. Responsibilities: Human-Centered Design Integration: Partner cross-functionally with engineering, design, commercial, clinical, regulatory, and quality teams to translate user needs into product design, including user interface (UI) requirements, labeling, packaging, and instructions for use. Usability Research Execution: Lead or support usability activities such as study design, protocol development, IRB submission, participant recruitment, data collection, moderation, analysis, and reporting for formative and summative studies. Use Risk Mitigation: Conduct comprehensive task analyses, root cause investigations, and use-related risk analyses to inform product design and identify use-related risks. Cross-Functional Influence: Serve as a key liaison between HFE and program team functional stakeholders to ensure human capabilities and limitations are reflected in product architecture and usability requirements, and human factors activities are considered at all stages of the product design lifecycle. Regulatory Readiness: Support the creation of HF documentation for regulatory submissions including HFE protocols/reports, URRAs, and other components of the overall HF File, all in accordance with global standards and FDA guidance. Stakeholder Engagement: Actively communicate and align with internal and external stakeholders to ensure user-centric solutions are embedded across development programs. Payrate: $60.00 - $70.00/hr. Summary: Company is seeking a results-driven and experienced Human Factors / Usability Engineer (HF/UE) contractor to support the Human Factors Engineering (HFE) team within the broader Combination Product Optimization (CPO) function. This role is critical in ensuring our drug delivery systems and combination products meet the highest standards of usability, safety, and regulatory compliance. This individual contributor will play a hands-on role across the product lifecycle, from early-stage user research through design input, usability testing, and preparation for FDA and global regulatory submissions. The ideal candidate will thrive in a fast-paced, matrixed environment and bring deep domain expertise in medical devices, combination products, and FDA-regulated usability engineering. Responsibilities: Human-Centered Design Integration: Partner cross-functionally with engineering, design, commercial, clinical, regulatory, and quality teams to translate user needs into product design, including user interface (UI) requirements, labeling, packaging, and instructions for use. Usability Research Execution: Lead or support usability activities such as study design, protocol development, IRB submission, participant recruitment, data collection, moderation, analysis, and reporting for formative and summative studies. Use Risk Mitigation: Conduct comprehensive task analyses, root cause investigations, and use-related risk analyses to inform product design and identify use-related risks. Cross-Functional Influence: Serve as a key liaison between HFE and program team functional stakeholders to ensure human capabilities and limitations are reflected in product architecture and usability requirements, and human factors activities are considered at all stages of the product design lifecycle. Regulatory Readiness: Support the creation of HF documentation for regulatory submissions including HFE protocols/reports, URRAs, and other components of the overall HF File, all in accordance with global standards and FDA guidance. Stakeholder Engagement: Actively communicate and align with internal and external stakeholders to ensure user-centric solutions are embedded across development programs. Qualifications: Ideal Candidate: 7-10 years of practical human factors experience in medical devices or combination products. Hands-on implementation experience required. Experience with auto-injectors, human factors validation, and engagement with the FDA or global regulatory bodies. Doctorate OR Master’s degree and 3+ years of experience in HF/UE within the medical device, combination product, or biopharmaceutical industries OR Bachelor’s degree and 5+ years of relevant experience Preferred Qualifications: Advanced degree in Human Factors or Usability Engineering Deep knowledge of applicable global guidance and standards: FDA: 21 CFR Parts 4, 820, 210/211, Human Factors Guidance, relevant device labeling standards
...Position: We are seeking an experienced Travel Specialist to lead and manage corporate... ...on coordinating complex domestic and international travel within the region, ensuring... ...in travel processes. Minimum Skills Required: Minimum 5 years of experience in corporate...
...: full time Daily pay available!Pay starts at $28.06Shift Differentials: Available for night, weekend, and additional shiftsLocation: St. Marys Jefferson... ...* Completion of a Radiology Technology programEXPERIENCE* No experience requiredPHYSICAL REQUIREMENTS* Constant...
...solutions-oriented, and ready to make an impact, youll find a rewarding and supportive home at i360. We are seeking a Senior RPA Developer to support a high-impact digital transformation initiative at the Federal Aviation Administration (FAA). This role is part of a...
...demonstrating a deep understanding of Allie Beth Stuckey's brand will be considered. Job Responsibilities : Oversee production of the podcast, taking ownership of the show's creative and operational success alongside host. Strategize content and brand direction for...
...Memory Care Aide (NIGHT SHIFT) at MASONICARE summary: The Memory Care Aide provides night shift support to residents in an assisted... ...11. Performs other duties as required Requirements: No experience required. CNA Certification is a must #joinourteam Keywords...