Job Title
R&D Manager - Please note this is an onsite role based in the Dublin office a minimum of 4 days per week
The Role
Responsible for management of people and departmental activities within the R&D/Product Development functions encompassing all activities leading to clinical and commercial approval. May lead product development projects.
Reporting Lines
Reports to Head of R&D or designate.
Key Responsibilities and Duties
The individual will work under minimal supervision while performing the following duties:
1. People Leadership
o Recruit, manage and develop Senior and R&D engineers, providing them with clear goals and objectives and development feedback and opportunities.
o Seek opportunities for the building of continuous clinical and technical knowledge and expertise within the staff.
o Support the development of departmental and program objectives, attached to a strategic plan, to ensure the CroíValve technology reaches its potential, and the departmental resources develop to facilitate this.
o Manage health and safety with the test laboratory.
o Support the development and maintenance of departmental budgets and resourcing plans.
o Ensure interactions with colleagues/stakeholders fully reflects the company values.
2. Technical
o Ensure the implementation of robust engineering practices and processes in the design and development of the product to ensure the final product is reliable and of the utmost quality.
o Ensure that test plans and testing executed aligns with regulatory requirements.
o Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies.
o Support clinical activities including limited clinical case support. Perform root cause investigations of identified product failure modes.
o Support the ongoing development of the Companies IP portfolio.
o Keep abreast of technological changes within the Tricuspid Heart Valve domain, ensuring that the company and staff are up to date with the state of the art in the areas of polymer material, nitinol, tissue engineering, test methods, imaging technologies among others.
o Keep abreast of changing regulatory standards, and how these can impact the planned technical work within the R&D and Product Development Activities.
3. Project Management
o May manage the development of new products for CroíValve that meet patient, customer and business needs.
o May serve as the Project Lead on one or more projects, developing plans and goals for the project which meet the overall company goals.
o Individually or in support role, develop project plans, timelines, budget and resource requirements and communicate these to stakeholders.
o Demonstrate collaborative leadership, being able to collaborate across multiple functions, beyond R&D.
o Manage external vendors/partners as necessary to support product development activities.
Essential Requirements
1. Technical: Strong technical capability with detailed understanding of technical principles, materials and processes used in the design and manufacture of medical devices and components. Applies extensive technical expertise to product development for areas under their responsibility. Ensures the application of strong engineering principles to ensure that the team designs and develops best in class, reliable medical devices.
2. People Skills: Has emotional intelligence and ability to build strong relationships and to positively influence collaborators/stakeholders throughout the organisation, as well as external partners.
3. Problem Solving: Facilitates a culture of collaborative, data-driven problem solving within the team to ensure timely resolution of technical issues with appropriate risk mitigation.
4. Project Management: Strong project management skills are required.
5. Initiative: Manages the work of others and self under limited supervision and takes initiative in communicating and alignment of project activities with stakeholders.
6. Communication: Communicates with stakeholders across the company and externally to develop project/product inputs, set and manage expectations and provide updates on project progress, risks and issues.
7. IP: Actively supports team innovation through regular contribution of disclosures to the company’s patent portfolio, and maintenance of the IP portfolio.
Education and Experience
1. Minimum of Bachelor’s degree in Mechanical or Biomedical Engineering, or related field.
2. Minimum of seven (7) years in a similar role in medical device product development, with a minimum of 3 years in project management/leadership role of technical projects across R&D and Manufacturing as a Senior or Principal R&D Engineer.
3. Good leadership and project management skills with the ability and willingness to effectively build and manage a small team.
4. Deep and current understanding of FDA and ISO 13485 requirements, with the ability to interpret these requirements and implement them into new product development.
5. Experience in design, verification, and process validation processes.
6. Broad knowledge of materials and manufacturing processes applicable to the medical device industry is desirable.
7. Experience working with sub-contract manufacturers/suppliers/test facilities.
8. Previous experience of the planning and preparation of regulatory submission to agencies, competent authorities and/or Notified bodies.
9. Excellent communication, organisational and time management skills.
10. Good problem-solving mindset.
11. Strong verbal and written communication skills.
12. At ease in start-up environment and effectiveness to deliver in low-structured environments.
13. Availability to travel is required.
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