Senior Medical Device Process Specialist

2 weeks ago

Galway, Galway, Ireland beBeeEngineer Full time €57,000 - €66,000
Job Opportunity:

The Senior NPI Process Development Engineer will be a key member of an interdisciplinary team responsible for creating and delivering complex acute ischemic stroke projects with significant technical challenges from initial concept through to commercialization.

Responsibilities:
  • Collaborate on cross-functional project teams to develop robust product designs ensuring capable manufacturing processes (Design for Manufacture).
  • Evaluate critical quality requirements for components used in building complex acute ischemic stroke devices and translate these requirements into component specifications that guarantee manufacturability and consistent performance.
  • Assess new and existing raw materials, components, and assembly suppliers for technical and manufacturing capabilities.
  • Promote process/product improvements related to sub-assembly or component usage or design.
  • Oversee prototype builds to support characterization and develop assessment strategies.
  • Develop strategies to characterize and validate new and improved manufacturing processes and components on external supplier manufacturing lines and pilot lines.
  • Collaborate with suppliers and incoming inspection laboratories to develop, validate, and ensure appropriate inspection methods and controls are in place for components and finished devices.
  • Identify project risks and develop mitigation strategies to ensure supply, quality, and timelines are met.
  • Monitor supplier performance and provide technical support to resolve issues.
Requirements:
  • Degree in Mechanical or Biomedical Engineering or equivalent.
  • At least 5-7 years of medical device process/device design and development experience in a regulated environment.
  • Prior experience in medical device catheter process design and/or manufacturing is highly desirable.
  • Understanding of product lifecycle and validation requirements for new product introduction.
  • Experience in developing validation strategies for equipment or processes, including preparation of FMEAs protocols and reports.
Benefits:

This role offers a very competitive hourly rate.

About Us:

We strive to create an inclusive work environment where diverse backgrounds, perspectives, and experiences are valued and each team member feels they belong and can reach their full potential.

  • Medical Device Compliance Specialist

    2 weeks ago

    Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €64,000 - €83,000

    Job DescriptionWe are seeking a highly skilled Senior Regulatory Affairs Specialist to lead our regulatory activities and ensure compliance with all relevant regulations. The successful candidate will be responsible for managing the entire lifecycle of products, from product certification and clearance to ongoing maintenance and improvement of our Quality...

  • Medical Device Development Specialist

    1 day ago

    Galway, Galway, Ireland beBeeDevelopment Full time €73,689 - €99,113

    Job Description:We are seeking a skilled Medical Device Development Specialist to join our team. This is a 12-month contract role that offers a competitive hourly rate and the opportunity to work on complex acute ischemic stroke projects with significant technical challenges.Key Responsibilities:Work collaboratively on cross-functional project teams to...

  • Medical Device Innovation Specialist

    2 weeks ago

    Galway, Galway, Ireland beBeeMedical Full time €23,000 - €52,600

    Job Title: Research and Development SpecialistAbout the Role:We are seeking an experienced Research and Development Specialist to join our team. As a key member of our engineering department, you will be responsible for designing, developing, and troubleshooting medical devices throughout the research and product development lifecycle.Key...

  • Senior Financial Analyst, Medical Device Manufacturing

    4 weeks ago

    Galway, Galway, Ireland FP&A Senior Finance & Executive Search Full time

    Our client, a global medical device manufacturer, has created a new Senior Financial Analyst job on their 25 person Finance team in Galway due to continuous growth of their local operations.Its the ideal avenue into the medical device sector if you have strong finance business partnering, budgeting and forecasting experience, or it can be the perfect step-up...

  • Senior Medical Device Developer

    2 weeks ago

    Galway, Galway, Ireland beBeeResearch Full time €98,000 - €124,000

    Job OverviewWe are seeking an experienced professional to join our team as a Senior Researcher.About the RoleWe are looking for a skilled and innovative individual to contribute to the development of cutting-edge medical devices. As a Senior Researcher, you will be responsible for designing and developing new medical devices from initial concept phase...

  • Medical Device Manufacturing Engineer

    15 minutes ago

    Galway, Galway, Ireland beBeeManufacturing Full time €72,000 - €108,000

    Process Development SpecialistOur innovative team is seeking an accomplished Process Development Specialist to join their ranks. As a key member of our product development team, you will be responsible for developing manufacturing processes, materials, and methods.The ideal candidate will have a proven track record in process development, with a strong...

  • Medical Device Quality Assurance Specialist

    12 hours ago

    Galway, Galway, Ireland beBeeQuality Full time €63,000 - €93,000

    Job Description:We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our medical devices. Your primary objective will be to identify and mitigate potential quality risks, ensuring that our products meet the highest standards of...

  • Medical Device Procurement Manager

    2 weeks ago

    Galway, Galway, Ireland beBeeSourcing Full time €85,000 - €114,000

    Nordson Medical, a global leader in the medical device industry, is seeking an experienced NPD Sourcing Specialist/Buyer to join their team in Galway, Ireland.Job Description:The NPD Sourcing Specialist/Buyer position is responsible for managing all aspects of sourcing and materials planning related to new product development & production of early stage...

  • Senior Medical Device Engineer

    2 weeks ago

    Galway, Galway, Ireland beBeeInnovation Full time €90,000 - €120,000

    Drive Innovation and Impact as a Senior EngineerWe are seeking a highly skilled and motivated individual to lead the development of cutting-edge medical devices.Lead Technical Development: You will be responsible for leading the design, development, and troubleshooting of catheter-based and other mechanical systems for medical devices.Collaborate with...

  • Senior Medical Device Research Engineer

    2 weeks ago

    Galway, Galway, Ireland beBeeMedical Full time €75,000 - €114,167

    We are seeking a dynamic and experienced Senior Research Engineer with a focus on medical devices to join our organization. The successful candidate will play a key role in the design, development, and testing of innovative medical devices that have the potential to improve patient outcomes and enhance healthcare practices.Key ResponsibilitiesLead the...