Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by up to 150 million people around the world.
Our approximately 21,000 employees are united around our mission of improving people's lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.
To lead and facilitate HFE/UE research, development and continuous improvement activities for the company's contact lens and solution products using HF/UE best practices and in accordance with current FDA, MDR and other global regulations and guidelines within the medical device industry.
The HFE/UE will lead appropriate human factors and usability engineering activities with cross functional teams to improve the design of products, specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for use errors.
Act as technical HFE/UE expert and increase company and employee knowledge on subject through training and improved usability of products
**The HFE/UE responsibilities include but are not limited to** :
+ Manage HF aspects of project including: planning, timelines, milestones, deliverables, resources, priorities and budget required.
+ Plan, conduct, analyze and report human factors activities supporting multiple projects.
+ Assist in defining user needs, translation of needs into measurable specifications, evaluation of device-user interfaces, usability studies throughout Research & Development and Product Life Cycle Management phases.
+ Ensure HFE/UE input is provided across functions to develop device design, packaging, labeling, and training requirements.
+ Support usability testing such as planning, protocol development, data collection sheets, moderator scripts, material development, study coordination, IRB submissions, managing participant recruitment, study management, data collection, analysis, and documentation to support project needs.
+ Write usability study protocols, perform statistical data analysis, and write summary reports
+ Assist in preparation for clinical studies and regulatory submissions in accordance with HF best practices.
+ Analyze objective and subjective data from usability studies to inform design and provide alternative solutions.
+ Active communication with internal and external key stakeholders.
+ Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, and HFE reports.
**SUPERVISE DIRECT REPORTS:**
+ Not at start, possible in future
**SCOPE OF POSITION** :
+ Technical expert in Human Factor and Usability engineering applied to both new product and legacy contact lens and solution products.May involve occasional domestic or international travel to other internal sites or external vendor
**KEY RELATIONSHIPS** :
+ Collaborate with external Human Factor Engineering consultancies, internal stakeholders, cross functional project teams, regulatory, quality, R+D
+ Education: Bachelor's Degree in Science or Engineering, Human Factors Engineering or Biomedical Engineering preferred. Master's Degree in Science, Engineering and/or Management preferred.
+ Computer Literacy with skills in Microsoft Excel, Word, Project and Powerpoint.
+ Functional knowledge of applicable guidance, regulations and standards including: FDA's Human Factors Guidance, 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, etc.
+ Demonstrated track record of success in Human Factors engineering in a fast-paced, collaborative environment
+ Ability to effectively communicate research results and recommend next steps.
+ Strong skills in formative and summative test procedures and execution
+ Ability to communicate and work collaboratively with development teams, marketing, clinical, and medical affairs.
+ Organized, self-directed, efficient, and able to manage multiple deliverables and workstreams in a timely manner while maintaining quality standards.
+ Must be able to develop working relationships with various internal core competencies, manage outside vendors, influence others outside of their immediate control.
+ Minimum of 10 years in Engineering, New Product Development, and/or Quality Engineering setting. ISO, FDA, GMP medical device manufacturing experience. Experience with high volume and/or high precision manufacturing a plus. Demonstrated leadership and ability to drive innovation, budgets, teams and risk based decision processes.
+ Experience in usability engineering, human factors engineering, risk analysis.
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Bausch Health Companies Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
**Job ID** _12573_
**Pos. Type** _Full Time_
Associated topics: biochemistry, bioengineering, biological engineer, biology, biomedical engineer, metabolic, msat, nutrition, pain, pathogenesis
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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