Human Factor Lead

Job description

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world. Why embecta? Imagine the long legacy and global scale of an industry leader combined with the agility, speed, and entrepreneurial energy of a startup—that's embecta. We are evolving from a company with more than 100 years of experience in diabetes care into a broader medical supplies organization, helping more than 30 million people worldwide live their best lives through innovative solutions, partnerships, and the strength of our global team. At embecta, you are empowered to take ownership, bring your authentic self to work, and accelerate your career alongside inspiring leaders. Reporting to the Head of Global Medical Affairs and Human Factors, you will provide technical and strategic leadership for human factors engineering and usability activities across the product lifecycle. The role partner with cross-functional teams to ensure products, interfaces, labeling, packaging and supporting materials are designed and evaluated with intended users, use environments, and use-related risks in mind. The position leads huma factors planning, research, formative and summative usability studies, prferences and comparative studies, risk-management inputs and preparation of clear, audit-ready documentation for regulated product development and lifecycle changes. In this key strategic and technical leadership role, additional responsibilities will be to ensure collaboration with peer leaders across R&D, Quality, Marketing, Safety, Operations and Regulatory functions as well as any other key stakeholders including those external to embecta. This role can be remote if not local to Parsippany, NJ What you'll be doing: Plan and conduct user research to characterize intended users, use environments, workflows, tasks, needs, capabilities, limitations, and foreseeable use scenarios. Design research questions, participant profiles, sample rationales, tasks, scenarios, success criteria, data collection methods, and analysis plan appropriate to the study objective. Collaborate with peer leaders in product development as well as technology development efforts. Partner internally and externally to implement best practices, regulatory standards, and guidelines to generate high-quality information to ensure innovative device design to meet unmet medical needs in alignment with embecta mission. Manage the human factors activities defined in program goals such as user interface, user experience, Instructions for Use (IFU), formative studies, and summative studies. Help shape the overall vision and strategy for human factors within embecta and support preclinical and clinical tests. Advise and inform leadership staff to develop strategy, tactics, and execution of development plans. Provide expert guidance, technical & process insight for core teams to overcome challenges and meet business expectations for product development. Author, review, and maintain human factors documentation, including human factors plans, user profiles, use environment descriptions, task analyses, known-use-problem analyses, use-related risk analyses, critical task rationales, study protocols, reports, and human factors engineering summary reports. Establish scalable templates, methods, quality standards, and decision frameworks that improve consistency and efficiency without reducing scientific rigor. Communicate complex human factors findings in a clear, decision-oriented language for technical, executive, and external audiences. Support post-market activities by reviewing complaints, use-related events, field feedback, and emerging use issues to identify potential trends and improvement opportunities. What We're Looking For: Required Qualifications: Minimum of a bachelor's degree in human Factors/Ergonomics Engineering, Applied Science in Industrial Engineering, Bioengineering, or a closely related technical or scientific degree is required. 8+ years of demonstrated experience (based on own subject matter expertise) in human factors engineering or equivalent user-based test experience. 8+ years of experience in product development; Medical Device experience highly desired. Strong experience with relevant medical device standards, including IEC 62366-1, ISO 13485, ISO 14971, FDA Guidance for Design Controls. Established expertise in areas including risk management, user needs research such as translating HF+UXD findings into user-needs/requirements, user risk and/or design solutions related to the user interfaces, management of human factors and usability engineering file. Excellent technical writing and documentation skills, with the ability to produce clear, concise, traceable and inspection-ready deliverables. Preferred Qualifications: A combination of Human Factors and clinical experience is preferred. Competitive base salary based on experience and qualifications: $126,000-140,000 (subject to variation depending on physical location). Posted salary ranges are provided in good faith. embecta reserves the right to adjust ranges depending on the selected candidate’s experience, qualifications, external market conditions, and internal equity considerations. Base pay is one component of the Total Rewards package at embecta, which also includes eligibility for an annual bonus . Benefits include medical, dental, vision, retirement savings plans, and paid time off. More details about our benefits programs can be found on our Careers page. #LI-KM1 embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.