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Senior Manager - Design Assurance

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 22501

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.


  • 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.

Education & Experience:

  • 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.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

091 706717