SoCode is partnering with a global leader in the healthcare industry to find two Principal Scientists for their Device and Product Performance team. Following recent internal promotions, these openings offer an opportunity to make a significant impact on the development of Combination Products.

In this role, you will utilise your experience in drug delivery systems or medical device development in order to lead the design and execution of testing strategies. You’ll collaborate with multi-disciplinary teams of Scientists and Engineers to ensure product performance and compliance with industry standards in the development of novel healthcare solutions.

The ideal candidate will have:

• A Degree in Science or Engineering (Master’s level preferred)
• Over 7 years of experience in the development of drug delivery systems and/or medical devices
• 3-5 years of hands-on experience with Combination Product Performance
• Solid understanding of design control practices, including medical industry standards (US, UK, EU)
• Strong expertise in developing and validating analytical testing methodologies
• Proficiency in applying statistical methods for data analysis
• Experience in preparing regulatory submissions and ensuring compliance with industry standards
• Proven experience as a Subject Matter Expert (SME), delivering presentations to both technical and non-technical audiences

Desirable experience:

• Knowledge in evaluating device functionality and conducting material assessments
• Specialized experience in test method development and device characterization

What will you be doing?

• Offering subject matter expertise to drive the development of Combination Products
• Leading a team to design and execute strategies for design verification and reliability testing
• Acting as the key technical liaison between drug product and device teams throughout combination product development
• Creating design requirements and specifications based on regulatory standards, user requirements, and comparison with competitor products
• Designing and implementing test methods to evaluate device performance
• Conducting material evaluations, biological assessments, and extractables testing for components
• Providing technical guidance during the development of manufacturing and assembly processes
• Leveraging statistical analysis to support design decisions and test method validations

Interested in the role? Then you can either:

• Submit your CV by applying to this job advert.
• Connect with Mo Baker at Socode Recruitment on LinkedIn for an informal discussion.
• Call our office for more information – Google SoCode Recruitment