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
Job Title Electrical Designer Job Location: Santa Clara Salary -80k to 165k Industry : Construction Position Overview We are an ENR top 10 Electrical Subcontractor that is rapidly growing and looking to add strong Electrical Designers to our team. The ideal...
...bring their products to life. Your Role at KIK We are looking for a proactive and experienced Environmental Health & Safety (EHS) Manager to join our team. In this role, you will be responsible for overseeing safety equipment inventory, conducting regular safety...
...Lactation Educator RN at Providence Health and Services summary: The Lactation Educator RN provides nursing support and education to encourage and assist breastfeeding for patients and staff at Kadlec Medical Center. This role requires a registered nurse with breastfeeding...
...brokerage firm is seeking a Brokerage Operations Coordinator in Ormond Beach, Florida. This entry-level position is ideal for recent graduates and offers a chance to support a busy brokerage team while developing skills in the financial industry. Responsibilities include...
...Technical Intelligence Analyst Cydecor is a premier Federal Government solutions provider, delivering... ...intelligence into broader all-source analysis Coordinate with Combatant... ...limited in your ability to access job openings or apply for a job on this site because...