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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.
Qualifications
  • 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.
Benefits
  • Competitive salary and bonus scheme.
  • Health insurance.
  • Pension.
  • Work life balance initiatives.
  • Career progression opportunities.
  • Inclusive environment.
Equal Opportunity Employer

Viatris is an Equal Opportunity Employer. We encourage applicants from diverse backgrounds to apply.

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