R&D Test Methods Engineer – Medical Devices

Role Overview

• Develop and validate test methods from initial requirements through final qualification
• Coordinate laboratory activities: daily organization, prioritization, resource allocation, coordination of tests
• Apply advanced statistical analyses: DOE, equivalence testing, inferential analyses, R&R, distributions
• Conduct experiments to identify influential factors and associated risks
• Maintain technological and regulatory watch in the fields of testing and metrology
• Support the R&D Test Laboratory Manager in optimizing workflows, ensuring test reliability, and capturing/leveraging test data
• Write and maintain validation documentation in accordance with regulatory requirements
• Manage measurement equipment and ensure metrological control and calibration
• Plan and monitor test method validation activities
• Deploy test methods: training, integration into protocols, monitoring for drift/deviations
• Review and revise test protocols
• Collaborate on multidisciplinary projects (R&D, Quality, Production, Laboratories)
• Serve as the technical interface with various user departments

Requirements

• Master’s degree (Bac+5) or engineering degree in physical/analytical sciences
• More than 5 years’ experience in testing/metrology
• Fluent English, spoken and written, is required
• Strong statistical skills (DOE, R&R, t-tests and F-tests, distributions) and mathematical modeling
• Experience in method validation in a regulated environment (ideally medical devices)
• Strong verbal and written communication skills
• Able to communicate technical issues in non-technical terms
• Experience coordinating a team or laboratory activities
• Project management skills and experience working with cross-functional teams

Tech Stack

• Flux

Benefits

• Supplementary pension scheme
• Generous leave and additional RTT days (30 days of paid vacation plus approximately 12 to 15 RTT days depending on the calendar)
• Attractive remote work/telecommuting options