Senior Manager - Design Assurance

Our client a major multinational based in Galway are looking for hire a Senior Manager - Design Assurance as they continue to expand operations. The Role: As Design Assurance Senior Manager you will be responsible for implementing and maintaining the effectiveness of the Design Controls systems across IDEM Manufacturing plants. Responsibilities:

• Develop and execute strategies to optimise Design Controls process within IDEM and ensure compliance and connectivity to the broader design assurance process requirements.
• Provide design assurance oversight to all functions operating in the New Product Introduction area.
• Define clear roles and responsibilities for all functions to ensure effective execution of the design controls process (R&D, RA, PM, Operations, Clinical).
• Ensure timely communication with VP of QA and Senior Leaders on critical design quality
• Manage resources to support product launches, appropriately matching skill set of individual direct reports to demands of projects, prioritizing efforts, anticipating technical issues and assuring successful project outcomes.
• Conduct/Coordinate regular and robust design reviews that provide assessment of issues, risks, and resource requirements for all phases of NPI projects.
• Ensure that product/process/package/label/Test Method designs and associated documentation comply with applicable Regulations for products distributed globally (US/OUS).
• Pro-actively monitor Post Market surveillance trends to ensure any potential design issues are addressed as well as developing a closed loop feedback system to the design process.
• Work closely with the R&D and Design Quality teams to ensure robust new product launch planning and successful design transfer process.
• Design Controls SME and person directly responsible to represent IDEM with outside Regulatory authorities (FDA, NMPA, Notified Bodies, MoH, WHO) on design quality.
• Participate in Regulatory Agency inspections and respond to queries related to product design controls, change control and complaints.
• Collaborate with Regulatory Affairs and R&D to establish appropriate product filing strategies and provide necessary product documentation for submission.
• Establish and execute design control policies, procedures, processes and principles to ensure robust product designs, appropriate evaluation during development and document change controls compliant with requirements.
• Collaborate with R&D in the development of Design test protocols and study plans and ensure both test plans and reports are compliant with all applicable regulatory requirements.
• Work with R&D to ensure that Product Test Methods are designed to provide the appropriate challenge to products and validated appropriately.
• Work with R&D to ensure successful and cost-effective product scale-up and technology transfer from R&D to commercial manufacture.
• Establish a post launch review process that monitors new product performance against the expected market performance and triggers escalation/intervention as necessary.
• Develop design assurance processes, systems, and Staff, delivering a high performing team that supports successful NPI execution across all IDEM Sites.

• Job requires extensive knowledge of Medical Devices and/or IVD design and manufacturing as well as experience in a fast-moving R&D environment.
• Proven track record of results managing projects in a highly regulated environment.
• Strong Leadership capability and ability to influence change balancing compliance with pragmatic
• Problem solving.
• Proven track record in delivering successful NPI programs on budget and on time.
• Proven track record in delivering Continuous Improvement programs.
• Must have strong technical ability and be articulate in message delivery.
• Ability to work and interact with several cultures across various time zones.
• Excellent written and verbal interpersonal skills to influence many diverse internal and external stakeholders.
• Ability to present complex technical information to Senior Management.

• Bachelor’s Degree – Engineering/Science/Life Sciences - Post graduate degree desirable.
• 5 years plus experience in a QA/R&D or other technical leadership role in a regulated environment.
• Experience managing in an environment with changing priorities and making appropriate risk-based decisions in the face of uncertainty.
• Experience managing a design assurance team is essential and preferably experience working with teams remotely.