Senior Product Development Specialist

3 days ago

Galway, Galway, Ireland beBeeDesign Full time €90,000 - €110,000

Job Title: Senior Design Quality Assurance Engineer

About Your New Role:

As a Senior Design Quality Assurance Engineer, you will lead design quality projects related to the drug-coated balloon product line, ensuring compliance with internal and regulatory requirements.

Your Responsibilities Will Include:

  • Leading design quality projects and ensuring compliance with all internal and regulatory requirements
  • Providing coaching and mentoring support within your reporting structure, including assignment and oversight of small to medium projects
  • Maintaining regulatory compliance with appropriate guidance documents such as company SOP/WIs and EU/FDA/Global guidelines
  • Working closely with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams to provide technical and quality systems input
  • Draw conclusions and make decisions from test data using excellent analytical and problem-solving abilities
  • Supporting internal and external regulatory audits as required
  • Providing support and direction for post market surveillance activities, such as Field Signal Evaluations, assessment of field product performance, NCEPs, Periodic Safety Update Reports (PSURs), and Q&A from regulatory authorities

Required Skills and Qualifications:

  • NFQ Level 8 qualification in a STEM discipline
  • Minimum of 6 years industry experience; Design Assurance experience is preferable
  • Experience in design control, risk management, design change, and standards compliance (to regulatory requirements)
  • Strong leadership, problem-solving, technical capabilities, communication, and collaboration skills
  • Proven ability to work well both as part of a team and individually
  • Enthusiastic and fully motivated to develop your career, demonstrate best practices, and drive improvements in product and process quality
  • Interested in coaching and developing team members

Benefits:

  • Competitive salary based on experience and qualifications
  • Career development opportunities within a dynamic and innovative company
  • Comprehensive benefits package including health insurance, retirement plans, and other employee benefits
  • Challenging work environment working on cutting-edge projects in a supportive and collaborative environment

  • Product Development Specialist

    3 days ago

    Galway, Galway, Ireland beBeeDevelopment Full time €70,000

    Our company is seeking a skilled Product Development Specialist to support senior engineers in executing test protocols and technical transfers.About the Role:As a Product Development Specialist, you will collaborate with cross-functional teams to refine product development procedures and contribute to ongoing improvements.You will participate in hands-on...

  • Advanced Product Development Specialist

    9 hours ago

    Galway, Galway, Ireland beBeeDevelopment Full time €70,000

    Job SummaryWe are seeking a highly motivated and experienced professional to join our team as an Advanced Product Development Specialist. In this role, you will be responsible for supporting senior engineers in executing test protocols and technical transfers, participating in hands-on testing and review of test methods, and collaborating on regulatory...

  • Product Development Engineer

    2 days ago

    Galway, Galway, Ireland beBeeEngineering Full time €80,000 - €110,000

    Senior Design Assurance SpecialistWe are seeking a highly skilled Senior Design Assurance Specialist to support our product development initiatives.Key Responsibilities:Develop and implement comprehensive design control processes, risk management strategies, and related systems for new product technologies.Collaborate with R&D project teams to ensure...

  • Senior Product Development Specialist

    9 hours ago

    Galway, Galway, Ireland beBeeProductEngineering Full time €60,000 - €90,000

    Job SummaryWe are seeking a senior product engineer to join our product development team.The role involves integrating electrical design into risk management, including DFMEA development, conducting electrical design reviews and ensuring integration between electrical hardware and firmware.Applying best practice electrical design techniques in areas such as...

  • Product Development Specialist

    1 day ago

    Galway, Galway, Ireland beBeeElectrical Full time €80,000 - €100,000

    A senior product engineer is needed to develop products for a company in Galway, Ireland.The ideal candidate has experience working on electrical engineering and medical device product development. Key responsibilities include integrating electrical design into risk management processes, conducting design reviews, and ensuring integration between hardware...

  • Senior Business Development Specialist

    2 days ago

    Galway, Galway, Ireland beBeeConsultancy Full time €40,000 - €60,000

    Senior Business Development SpecialistThe Role:As a Senior Business Development Specialist, you will be responsible for providing expert consultancy to prospective clients on a range of pre and post-retirement products, protection and pensions. Your key responsibilities will include:Meeting with clients and generating new business leads through project...

  • Product Specialist

    3 days ago

    Galway, Galway, Ireland beBeeproduct Full time €35,000 - €50,000

    Product SpecialistWe are seeking a Product Specialist to join our operations. As a Product Specialist, you will be responsible for operating on the production floor, performing activities such as CNC Machining, Non-Destructive Testing (NDT) Inspection, Robotic Finishing, and Cosmetic Inspection."] ,

  • Senior Product Development Specialist

    2 days ago

    Galway, Galway, Ireland beBeeProductDesigner Full time €45,000 - €80,000

    Job Title: Design EngineerKey Responsibilities:Project manage new product development and upgrading of existing products.Develop product designs based on technical specifications provided.Implement design for manufacture and design for assembly techniques.Conduct technical reviews of requirements, specifications, designs, codes, and other requirements.The...

  • Senior Production Development Specialist

    1 day ago

    Galway, Galway, Ireland beBeemanufacturing Full time €60,000 - €120,000

    Manufacturing Engineer PositionThis is a key role within our production team, focusing on the development and improvement of manufacturing processes.

  • Advanced Electrical Product Development Specialist

    2 days ago

    Galway, Galway, Ireland beBeeProductEngineer Full time €120,000 - €140,000

    Senior Product Engineer Role">This is an exciting opportunity for a Senior Product Engineer to join our team in Galway. The successful candidate will be responsible for leading the development of electrical products, working closely with other design teams to root cause design issues and ensure integration between electrical hardware and...