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Senior R & D Engineer

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

Job description

Our Client a cutting edge medical device company based in Galway are hiring a Senior R & D Engineer to join the team.

Responsibilities include but are not limited to:

Product Development and Design

  • Lead product development from concept through to manufacturing readiness, ensuring products are safe, effective, and user-focused.

  • Contribute to technical reviews, interpret experimental data, and influence design direction through brainstorming sessions.

  • Develop prototypes and refine designs using techniques such as vacuum forming, injection moulding, dip moulding, heat sealing, laser cutting, and 3D printing.

  • Evaluate and source materials, components, and suppliers to optimize design and manufacturability.

  • Communicate design decisions clearly, interpret research literature and test results to enhance product designs.

  • Create and maintain comprehensive design documentation, including drawings, specifications, technical reports, user needs, product requirements, and traceability matrices.

Testing, Analysis, and Development

  • Build prototypes to validate design concepts and ensure safety and effectiveness.

  • Develop and implement test methods for product safety and performance validation.

  • Predict design outcomes through mathematical modelling, digital analysis, and experimental validation.

  • Utilize user testing groups to gather real-world insights and iterate on designs.

  • Collaborate with the Verification & Validation (V&V) engineer to validate test methods for design verification.

Quality Assurance and Compliance

  • Collaborate with design assurance teams to conduct risk assessments using Failure Mode and Effects Analysis (FMEA).

  • Ensure all product designs comply with relevant regulatory standards, including FDA guidance, MDR, ISO 13485, and IEC 60601.

  • Maintain Design History File (DHF) documentation, including Design Inputs, Test Method Design & Validation, and Design Verification Plans.

Project Leadership and Execution

  • Take ownership of critical and complex technical tasks, driving project success and maintaining timelines.

  • Collaborate with the R&D Lead, Project Manager, and RA/QA teams to ensure project alignment and uphold quality standards.

  • Manage external suppliers and manufacturing partners, ensuring timely delivery and alignment with project goals.

  • Provide technical leadership and mentorship to junior team members, fostering growth and expertise within the team.

Cross-functional Collaboration

  • Work closely with manufacturing engineers to ensure Design for Assembly (DFA) throughout the design process.

  • Lead cross-functional teams to develop user-focused medical devices that improve patient outcomes.

  • Participate in technical discussions, contributing ideas to enhance product functionality and manufacturability.

Job requirements

  • Experience and Expertise:

    • Minimum of 6+ years of R&D experience, with at least 4+ years in the medical device sector.

    • Proven track record in product design and development, including design for assembly/manufacturing.

    • Expertise in Design History File (DHF) documentation and Design Verification Plans.

    • Hands-on experience with manufacturing processes such as injection moulding, vacuum casting, dip moulding, and rapid prototyping (3D printing).

    • Strong understanding of medical device regulatory requirements, including FDA guidance, MDR, ISO 13485, and IEC 60601.

  • Technical Skills:

    • Proficiency in developing robust test methods for evaluating designs and guiding iterations.

    • Familiarity with Quality Management Systems (ISO 13485) and compliance with industry standards.

    • Experience with risk assessments using Failure Mode and Effects Analysis (FMEA).

  • Leadership and Collaboration:

    • Proven ability to lead cross-functional teams and collaborate effectively across departments.

    • Experience in managing external suppliers and manufacturing partners.

    • Strong communication and collaboration skills, with the ability to convey complex technical concepts clearly.

  • Personal Attributes:

    • Creative: Problem solver with enthusiasm for exploring innovative solutions.

    • Open and Collaborative: Team player who actively contributes to a positive company culture.

    • Communicative: Proficient in written and verbal communication, able to articulate ideas effectively.

    • Self-Driven and Organized: Highly motivated with a sense of urgency and the ability to manage multiple tasks.

    • Methodical Approach: Structured and analytical in problem-solving and product development.

Experience Advantages – Preferred but Not Required

  • Experience working with wearable products involving textiles.

  • Proficiency in CREO CAD software.

  • Experience in design for sterilization.

  • Familiarity with testing autoinjectors and/or vascular access devices.

  • Prior experience designing and executing usability studies, incorporating human factors into product design.

  • Experience with electromechanical and pneumatic device design

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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