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

McDermott Laboratories Limited

• Provide Design Assurance and Risk Management 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.
• Manage, review, and approve change controls issued from the commercial site or from GDD which are deemed to impact the device/combination product.
• Provide Design Assurance and Risk Management support 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.
• Review and Approval of Technical Operation Output Documentation.
• 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 14971, 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, and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Opportunity to access excellent career progression opportunities and work-life balance initiatives.

Viatris is an Equal Opportunity Employer.