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Research And Design Contractor

  • On-site
    • Galway, Connaught, Ireland
  • Engineering (Design/ R&D / Mechanical / NPI)

Job description

Our client, an exciting multidisciplinary medical device start-up based in Galway is hiring a Senior Research & Design Contractor to collaborate with the R&D Project Lead and ensure the R & D function stays on track to meet the project deliverables and milestones where applicable. 


Responsibilities include but are not limited to the following:

  • Project Execution and Alignment: Collaborate with the R&D Project Lead to manage project timelines and objectives, ensuring deliverables are achieved on schedule and align with business goals. Proactively address any issues to keep the project on track.
  • Product Design and Development: Lead the design, prototyping, and testing of medical device products, ensuring adherence to design and development principles while delivering innovative solutions. Develop detailed specifications, drawings, and design documentation.
  • Design Verification and Validation (V&V): Create and execute design verification and validation plans to ensure products meet intended use requirements. Oversee the development of testing protocols, analyze results, and implement design modifications as needed.
  • Regulatory Compliance and Documentation: Ensure all activities are compliant with regulatory requirements, including 510k submissions. Maintain comprehensive design history files (DHF) and related documentation to support regulatory filings and audits.
  • Risk Assessment and Management: Conduct process Failure Mode and Effects Analysis (FMEA) to evaluate potential risks throughout the design and development process. Identify risk mitigation strategies and implement necessary design improvements.
  • Vendor and Supplier Management: Engage and manage relationships with external vendors and suppliers, negotiating terms and ensuring the timely procurement of high-quality materials and components necessary for product development.
  • Human Factors Engineering Integration: Integrate human factors and usability considerations into the design process to ensure products are user-friendly, safe, and effective. Work closely with user feedback and testing data to refine the design.
  • Cross-Functional Collaboration: Work with cross-functional teams, including Quality Assurance, Manufacturing, and Regulatory Affairs, to facilitate a smooth transition from R&D to production. Ensure design intent is preserved through each phase of product development.
  • Continuous Improvement Initiatives: Identify opportunities for process improvements within the R&D department, contributing to a culture of continuous improvement and innovation within the start-up.
  • Reporting and Documentation: Prepare comprehensive reports and presentations on project status, design changes, and testing outcomes. Ensure that documentation is clear, concise, and available for review by stakeholders and regulatory bodies.
  • CAD and Prototyping Support: Utilize CAD tools like Solidworks to develop 3D models and support prototyping activities. Refine designs based on testing results and technical feedback, ensuring efficient transition to manufacturing.
  • Problem-Solving and Decision-Making: Apply critical thinking skills to troubleshoot design and process challenges, using data-driven insights to make informed decisions and optimize product performance

Job requirements

  • Minimum Bachelor’s degree in science, engineering, or related field or equivalent.
  • Minimum of seven (7) years in a similar role in Medical device R&D or equivalent.
  • Experience working under medical device design controls, with proven knowledge of design verification/validation and process FMEAs.
  • Experience in medical device design and development principles, design validation and test method development essential.
  • Experience in 510k submissions is essential
  • Strong vendor management and negotiation skills.
  • Experience in Human Factors Engineering is desired.
  • Strong desire to contribute to the development of a startup organization.
  • Strong initiative and follow through in executing responsibilities
  • Excellent problem solving, critical thinking and decision-making skills.
  • Strong communication skills; strong report writing and administration skills.
  • Fluency in English is essential.
  • Proficiency with CAD software (Solidworks) is required


Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

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