Scientist/Engineer, Device Technical Operations (Analytical) (18 Month Fixed Term Contract)

McDermott Laboratories Limited

• Provide technical support for the transfer of manufacturing of Devices and Combination Products from the Global Device Development (GDD) Group in R&D to commercial manufacturing sites as per the GDD design control process in compliance with ISO 13485 and 21 CFR 820.
• Act as the interface between R&D and the commercial manufacturing sites during device/combination product development and provide support for the troubleshooting of all device related issues/investigations.
• Manage, review, and approve change controls issued from the commercial site or from GDD which are deemed to impact the device/combination product.
• Develop manufacturing process understanding by use of tools such as Cause and Effect, providing linkage to all aspects of manufacturing and utilized to identify any potential failures.
• Provide technical support and act as technical SME on site as required at suppliers or manufacturing sites for device-related complaints, support device-related investigations to root cause and the establishment of appropriate corrective actions.
• Generate technical documentation to support medical device / combination product such as the following:

• Degree in Engineering/Science
• Previous experience of Technical Transfer and/or Technical Support in high volume GMP manufacturing environment for devices and/or combination products.
• Experience authoring technical reports and producing high quality documentation within a regulatory controlled GMP environment.
• A working knowledge of MDR 2017/745, ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
• It is essential that the candidate will be both highly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams.
• The candidate must be able to work under pressure and have a proven track record of problem solving and effective time management.
• Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders.
• Willingness to travel as necessary between the Global Device Development Teams, Affiliates & suppliers.

• Competitive salaries
• Benefits
• Inclusive environment
• Career progression opportunities
• Work life balance initiatives

Viatris is an Equal Opportunity Employer.