|Role Type||Fixed Term Contract|
R&D Sustaining Engineer
Job ID: JOB-11778
R&D Sustaining Engineer
About the Role
- We are seeking a highly motivated R&D Engineer to join the Galway Structural Heart Valves (SHV) Sustaining R&D team. This is one of the most exciting areas of growth.
- The successful candidate will join a dynamic interdisciplinary team of engineers working on transcatheter heart valve devices post commercialisation.
- The SHV Sustaining Engineering R&D group provide design support to commercial products in many varied projects that ensure safety, compliance and manufacturing continuity of this new product portfolio.
- Responsible for supporting commercialisation of next-generation minimally invasive medical devices for the treatment of valvular heart disease. Successful candidate will work as a member of a team within a dynamic New Product Development organisation specialized in transcatheter heart valve system development for commercialization in all major global healthcare markets.
- Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to enable design intent to be maintained on commercialised products whilst also helping provide post launch support by being a source of key product and clinical knowledge.
- Use of design change process to ensure proposed changes are systematically and thoroughly analyzed before beginning the change process. Whenever product changes are proposed, justification is written or data is collected to verify that the design intent is still met.
- Works cross-functionally with project management, quality, manufacturing, regulatory, clinical and marketing to ensure project success.
- Work collaboratively with manufacturing to reduce product costs through design improvements.
- Works with other functions to understand feedback from the market, providing design knowledge input to understand device performance and anatomy interaction, look for opportunity for device improvement and interact with physicians as necessary to optimise outcomes.
- Interfaces with vendors and physicians where projects require.
- Demonstrates design control knowledge through generation of high quality deliverables
- Maintain product performance through Quality Investigations and ensuring rigorous support for design changes.
- Works independently to plan and schedule own activities necessary to meet timelines.
- Designs and coordinates standard engineering tests and experiments.
- Designs, procures and fabricates tooling and fixtures.
- Performs troubleshooting on products/process problems as related to design, material or process.
- Summarizes, analyzes and draws conclusions from test results.
- Prepares standard reports/documentation to communicate results to technical community.
- Responsible for engineering documentation.
- Invents/creates concepts and designs for new products/processes, and submits idea disclosures.
- May train and/or provide work direction to technicians and interns.
- May support integration of newly acquired technologies/products where required.
- Must be able to provide technical guidance within a team and be an effective communicator within a multidisciplinary and international organisation.
- Applies Mechanical and Biomedical Engineering to create/develop technical capabilities and expertise related to the design and testing of heart valve technology.
- Devises strategies for efficient execution of project deliverables and communicates changes in project milestones to key stakeholders and writes project reports as required
- Leads or participates in a cross functional team to perform troubleshooting on products/process problems as related to design, material or process.
- Understands and complies with complex regulations, including FDA & ISO, governing the quality systems
- Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers related to materials, manufacturing processes and design
- Demonstrates a primary commitment to patient safety and product quality.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- HETAC Level 8 Degree in a relevant Technical Discipline, preferably Mechanical, Polymer, Materials or Biomedical Engineering.
- Strong R&D/technical experience preferably in the health care industry
- Excellent interpersonal and communication skills with proven leadership abilities.
- Excellent analytical and problem-solving skills.
- Candidates should have a proven track record of working in a fast paced environment with strong technical capabilities and be capable of handling multiple development aspects of assigned projects.
For further information on this role in Galway please contact Ciaran Fahy on 0874108620/ firstname.lastname@example.org
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