Director, Device User Interface
Posted 17 days 9 hours ago by 1100 Mylan Pharmaceuticals Inc.
Permanent
Full Time
Other
Dublin, Ireland
Job Description
Job Overview 
Title: Director, Device User Interface
Responsibilities- Lead a high performing team in translating user needs, use scenarios, and use related risks into robust, traceable design inputs fully aligned with program plans.
- Guide end to end Human Factors activities from early formative evaluations at program initiation to validation activities, including summative HF studies, comparative analysis, and comparative use HF studies.
- Ensure comprehensive evaluation of methodology, identify improvements, and secure stakeholder acceptability.
- Champion continuous improvement in User Interface processes, tools, and governance to enhance development efficiency and compliance.
- Mentor and develop the team, fostering a culture of innovation, collaboration, and continuous improvement.
- Establish KPIs and provide timely reporting to GDD leadership.
- Contribute to portfolio strategy, plan and monitor all activities to ensure engagement, right content, quality, and timing.
- Guide the User Interface strategy for medical devices and drug device combination products, ensuring regulatory alignment, intuitive design, accessibility, and patient centric usability.
- Drive efficiency in documentation through standardisation, technology, and training, resulting in clear, inspection ready user interface documentation.
- Drive innovation in device design by identifying emerging trends, new technologies, and industry best practices.
- Maintain partnerships with global business owners and functional lines; collaborate with Device Design, Clinical, Regulatory Affairs, and Quality teams.
- Represent the company externally as required.
- Oversee external vendors and study execution, ensuring methodological rigor, compliance, and timely delivery of human factors evidence.
- Essential: Degree in Pharmaceutical Science, Medical Device/Product Design, or equivalent.
- Minimum 5 years in a leadership role in Pharmaceutical Development, Human Factors Engineering, or Medical Device/Combination Product Engineering.
- Proven track record of leading development strategy and program execution.
- Strong oral and written communication skills.
- Experience working with external partners and project management.
- Knowledge of drug delivery technologies (pen injectors, autoinjectors, vial kits, inhaler technologies, prefilled syringes).
- Detailed knowledge of industry standards: EU MDR, ISO 13485, ISO 14971, ISO 62366, 21CFR Part 820.
- Desirable: MSc, PhD, or MBA.
- Experience in medical device/combination product design control activities with integrated risk management and human factors/usability engineering studies.
- Experience in both NCE and Generic product development with understanding of regulatory pathways.
- Experience submitting/filing sections against drug delivery systems for regulatory agencies.
- Competitive salary and bonus scheme.
- Health insurance.
- Pension.
- Work life balance initiatives.
- Career progression opportunities.
- Inclusive environment.
Viatris is an Equal Opportunity Employer. We encourage applicants from diverse backgrounds to apply.