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Job Details
Research and Development Engineer II
- ID
- 15047
- Location
- Mayo
- Role Type
- Permanent
- Contact
- Johanne Kennedy
Research and Development Engineer II
The R&D Engineer will play a key role in the design, development, and testing of medical devices and systems. Focus will be on learning, developing technical skills, and applying knowledge.
Responsibilities
- Works on well-defined tasks and projects with guidance from senior engineers or managers
- Support the design and development of products including a high-level of design feasibility, prototype development, design, test method development, design verification/validation, and product commercialization
- Application of both new and existing technologies, materials, and processes to deliver a product Supports the creation of engineering specifications, drawings, and prototypes
- Ability to learn CAD Software (i.e. Solidworks) to develop and design concepts, components, and systems
- Develop prototypes and conduct hands-on testing to evaluate functionality and durability Support feasibility studies and risk assessments to ensure products meet regulatory requirements, performance specifications, and safety standards Support testing protocols to validate device performance against design specifications
- Understanding of problem-solving behaviors and activities such as Root Cause Analysis, Design of Experiments (DOEs), and other problem-solving tools
- Conduct analysis of data and develop detailed reports and recommendations
- Collaborate with clinicians and end-users to gain an understanding of their needs.
- Support the creation of user needs and ensure the optimization of product functionality and performance based upon their feedback.
- Prepare technical documentation in accordance with regulatory and design control requirements
- Develop and maintain relationships with cross-functional team members (i.e. marketing, design assurance, global engineering, operations, project management, clinical)
- Analyze existing devices and processes to identify opportunities to enhance customer needs, quality, cost, and/or production
Educational And Experience Requirements
- Bachelor’s degree in Science related discipline and minimum 2-5 years of experience OR Master’s Degree in Science or Engineering preferred Experience in Research & Development, ideally in medical device industry
- Experience in project management
- Experience in quality
- Solid understanding and capable of designing and developing medical devices across various stages (concept, prototyping, testing, production)
- Some experience with Design Controls including documentation of design history files (DHF), risk management files, failure mode effects analysis (FMEA), traceability matrices, and verification and validation (V&V) processes
- Ability to learn, execute tasks, and build experience Familiarity with ISO 13485 (Quality Management System for Medical Devices)
- Experience with prototyping
- Effective verbal and written communication skills both Lithuanian and English Experience collaborating across multidisciplinary teams (marketing, design assurance, engineering, operations, regulatory, clinical, etc.)
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