Senior Analytical Device Testing Lead

As the analytical lead for device-related testing activities, you will act as the primary point of contact for analytical activities across development projects. You will define testing strategies, coordinate internal and external laboratories, support regulatory submissions, and ensure compliance with pharmacopeial and international standards.

• Act as the single point of contact for analytical device testing activities within cross-functional project teams.
• Lead and oversee analytical activities for assigned development projects.
• Develop, optimize, and transfer analytical methods to internal and external laboratories.
• Select and manage testing laboratories in alignment with project needs and outsourcing strategies.
• Coordinate and monitor outsourced analytical activities and external partners.
• Apply and interpret ISO standards, European Pharmacopoeia (Ph. Eur.), and United States Pharmacopeia (USP) requirements.
• Provide technical expertise in analytical mechanical testing methods for drug delivery devices and combination products.
• Analyze and interpret statistical data using tools such as Minitab.
• Contribute to regulatory documentation, submissions, inspections, and project registration activities.
• Collaborate closely with development, quality, regulatory affairs, and external stakeholders to ensure project success.

• MSc or PhD in Engineering, Pharmaceutical Sciences, Analytical Sciences, Medical Devices, or a related field.
• Significant experience in analytical testing of medical devices and/or combination products.
• Strong expertise in ISO standards, USP, and Ph. Eur. requirements and their practical application.
• Proven experience with analytical mechanical testing methods and device verification activities.
• Advanced knowledge of statistical analysis and practical experience with Minitab or equivalent software.
• Experience managing analytical activities across multiple stakeholders and external laboratories.
• Strong understanding of regulatory requirements for combination products and device development.
• Excellent communication and coordination skills within international cross-functional teams.
• Fluent English, both written and spoken.