Device and Product Performance Scientist

Role & What You Will Be Doing

Lead the development of combination product methods for the R&D Laboratory while providing technical mentorship to junior team members, including guidance on technical issues and review/approval of documents, and supporting the lab manager.

• Provide technical laboratory expertise to support the development of combination products.
• Support a team responsible for activities such as metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, and transport & shipping studies.
• Develop and validate test methods to support design verification testing at internal or external test facilities or manufacturing sites.
• Coordinate with Viatris affiliates and third-party partners to support exhibit and registration batches, reviewing and implementing controls and additional requirements as necessary.
• Oversee testing of combination products within the Global Device Development portfolio, generating protocols, supervising execution at external facilities, and writing reports.
• Conduct trending and statistical analysis of analytical data, compiling technical reports to support the product development lifecycle.
• Ensure compliance with reliability requirements through appropriate controls and assessment against specifications.
• Compile and review technical documentation within GDD in line with global regulatory requirements.
• Lead and review device investigations and participate in GDD and technical investigation teams as required.
• Record aberrant results using Trackwise.
• Support all R&D lab activities, including equipment calibration and qualification, documentation requirements, and Trackwise record keeping.
• Attend EHS training and adhere to EHS procedures, ensuring appropriate risk assessments for tasks.

About Your Skills & Experience

• Experience in the development and validation of analytical methods (advantage).
• Experience applying statistical techniques for data analysis.
• Masters or Degree in Engineering or Science with a minimum of 2 years' experience in a laboratory environment.
• Previous experience in a regulated GMP environment is an advantage.
• Proficiency with Minitab (advantage).
• Highly driven and motivated, capable of working as part of a flexible, dynamic team while taking responsibility for individual tasks.
• Working knowledge of design control requirements in line with FDA 21 CFR Part 820 and ISO 13485 (advantage).
• Well developed communication skills to lead or facilitate effective discussions and to communicate technical or project information to key stakeholders.
• Travel may be required.

Benefits

• Competitive salary
• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Viatris is an Equal Opportunity Employer.