CroíValve are looking for a Senior R&D Engineer to Support the product development of a cutting-edge structural heart device through design development, verification, clinical trials, validation and regulatory approval. This role will focus primarily on the design and testing of the implant and anchor system with a focus on test method development. This role is based on site in Galway or Dublin R&D office.Reporting LinesReports directly to the Head of R&D or designate.Key Responsibilities and DutiesResponsible for developing device specifications, in line with user needs and Design Inputs, including innovative solutions. Provide technical and project leadership for R&D activities.Design sub assemblies and finished devices, including design selection, material selection and assembly method selection. Create detailed component and finished device assembly drawings/specifications.Build and test prototypes; analyse test data and interpret to identify optimal solutions.Identify and select product materials, assembly methods and define process settings. Participate in sourcing, testing and approving materials.Develop test methods for product evaluation and validation. Develop and execute test method validations.Leverage and liaise with external resources to achieve project goals.Drive risk management for sub-assemblies under their responsibility and drive a system level risk based design approach.Ensure quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability.Ensure interactions with colleagues/stakeholders fully reflects the company values:One Team: working together to ensure the whole is greater than the sum of the partsPersonal Ownership: deliver on commitmentsOpen Communication: Honest open-minded communicationFun: celebrate the successesContinuous Learning: at an individual and company levelSolution Orientated: Identify problems but focus your energy on solutionsQuality Focused: patient safety comes firstEssential RequirementsTechnical: Strong technical capability with detailed understanding of technical principles, materials and processes used in the manufacture of medical devices and sub-systems. Applies extensive technical expertise to product development for areas under their responsibility. Provides solutions to difficult technical issues associated with specific projects.Problem Solving: Supports a culture of data-driven problem solving that ensures development of high quality devices. Promotes best practice in relation to capturing, analysis and communicating data to feed into technical decision-making across the company.Innovation/ IP: Actively supports team innovation through regular contribution of disclosures to company’s patent portfolio.Project Management: Effective project management skills, including planning, scenario and contingency mapping. Management of activities at a sub-system level, including delegation of discrete work package to more junior engineers. Ensures timelines are met. Effective in identifying and communicating project risks and requirements to mitigate these risks. Contributes through self and others to ensure completion of projects. Effectively generates budget needs for development at sub-system / system level by mapping out activities and resource requirements.Initiative: Takes initiative to drive continuous improvement and reach business objectives. Leads discussions to drive team decisions as required.People Skills: Strong ability to build relationships and resolve people issues that arise. Positively influences team and cross-functional interactions. Mentors junior team members and sets a positive example for the team, encouraging growth of more junior engineering staff.Communication: Demonstrated ability to communicate effectively with internal and external stakeholders. Strong presentation of technical information to guide the decision-making process.Education and ExperienceB.S. or master degree in mechanical engineering, biomedical engineering, or related disciplines.Minimum of four years of related experience in medical device mechanical design/product development.Project management skills – capable of operating and liaison at all levels including managerial, project and technical.Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles.Strong capability of assessing in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.Ability to manage self and others to achieve challenging targets.Demonstrated analytical problem-solving abilities to resolve complex technical issues.Class III medical product development experience preferred. Prior experience in cardiovascular/nitinol/delivery system/stent medical products highly preferred.Detailed knowledge of Design Controls and FDA, GMP, QSR and ISO 13485 requirements.Experience interfacing with clinicians and reducing feedback to device concept.Experience of preparing technical documentation.Excellent people, communication, organizational and time management skills.Flexibility to travel to vendor or clinical sites to support project activities.The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned from time to time.
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