Senior Research & Design Engineer

Full Job Description

Our client, an exciting multidisciplinary medical device start-up based in Galway is hiring a Senior  Research & Design Engineer. The successful candidate will report to the R&D Project Lead and will get the opportunity to apply engineering knowledge in areas such as design, test method development and validation, CAD and design controls. 

Responsibilities include but are not limited to the following:

• Taking charge of projects and oversee their progress throughout all stages of development, ensuring the achievement of project milestones within specified timelines.
• Fostering innovation and creativity within the team by providing mentorship, coaching, and developmental opportunities to direct reports.
• Facilitate problem-solving efforts by coordinating initiatives to identify root causes and implement effective solutions. Perform advanced data analysis and generate comprehensive reports that document findings, draw conclusions, and provide actionable recommendations.
• Contribute to the preparation of project proposals, development project plans, detailed project schedules, product design input requirements and design verification test plans.
• Supporting design/development of our product including concept development, design feasibility, prototype development, detailed design and DFM, design verification/validation activities.
• Application of new and existing technologies, materials and processes to deliver the optimum product design ensuring excellent standards of performance.
• Introduce/develop new equipment and production processes as required for any new manufacturing techniques. Monitoring of equipment maintenance calibration.
• Preparation of technical documentation in accordance with regulatory and design control requirements and with the company's development processes. Including part and material specifications, technical drawings and engineering protocols/reports for support of FDA and EU
  MDR submission.
• Engaging with Vendors and suppliers on a regular basis to ensure efficient delivery of services.
• Participating in test method development and test method validation.

• An honours Bachelor's Degree in an Engineering or related discipline is required.
• 5+ years product development in medical device design is required.
• Technical Project lead experience
• Ability to contribute to the preparation of project proposals, development project plans, detailed project schedules, product design input requirements and design verification test plans.
• Experience in medical device design principles, material selection, design concept validation and test method development essential.
• Demonstrated understanding of various types of manufacturing, mechanisms, materials, tolerance-analysis and design-for-manufacturing principles.
• Experience of working under medical device design controls, with proven knowledge of design verification/validation and design/process FMEAs.
• Proficiency with CAD software (Solidworks) is required.
• Experience of medical device regulations including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO quality requirements is required.
• Strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience is required.
• Excellent problem solving, decision making and root cause analysis skills are desired (DMAIC)
• Proficiency with MS Office suite is required.
• Proficiency with statistical software (Minitab) is desired.
• Practical knowledge of FEA Software (Ansys) is desirable.

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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