Director, Device User Interface

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary and bonus

Health insurance

Pension

Work–life balance initiatives

Career progression

Inclusive environment

Job summary

1100 Mylan Pharmaceuticals Inc. in Ireland seeks a Director of Device User Interface to lead a high‑performing team and translate user needs into robust, traceable design inputs aligned with program plans.

You will guide end‑to‑end Human Factors activities from formative evaluations to validation and influence portfolio strategy across key functions. The role requires leadership in medical device/combination product design‑control with integrated risk management, regulatory awareness (EU MDR,

Qualifications

• 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.
• 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.

Responsibilities

• Lead a high‑performing team translating user needs into robust, traceable design inputs aligned with program plans.
• Guide end‑to‑end Human Factors activities from formative evaluations to validation.
• Ensure comprehensive evaluation of methodology and stakeholder acceptability.
• Champion continuous improvement in UI processes, tools, and governance for efficiency and compliance.
• Mentor and develop the team, fostering innovation and collaboration.
• Establish KPIs and report to GDD leadership.
• Guide the UI strategy for medical devices and drug device combinations, ensuring regulatory alignment and patient‑centric usability.
• Drive efficiency in documentation through standardisation and training.
• Drive innovation in device design by identifying emerging trends and 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 and timely delivery of human factors evidence.

Skills

Leadership

Communication

Project management

Stakeholder management

Education

Degree in Pharmaceutical Science/Medical Device Design

MSc/PhD/MBA (Desirable)

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.