R&D Manager

Overview

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 Responsibilites and Duties

The individual will work under minimal supervision while performing the following duties :

Recruit, manage and develop Senior and R&D engineers, providing them with clear goals and objectives and development feedback and opportunities.

Seek opportunities for the building of continuous clinical and technical knowledge and expertise within the staff.

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.

Manage health and safety with the test laboratory.

Support the development and maintenance of departmental budgets and resourcing plans.

Ensure interactions with colleagues / stakeholders fully reflects the company values

Technical

Ensure the implementation of robust engineering practices and process in the design and development of the product to ensure the final product is reliable and of the utmost quality.

Ensure that test plans and testing executed aligns with regulatory requirements.

Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies.

Support clinical activities including limited clinical case support.

Perform root cause investigations of identified product failure modes.

Support the ongoing development of the Companies IP portfolio.

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.

Keep abreast of changing regulatory standards, and how these can impact the planned technical work within the R&D and Product Development Activities.

Project Management

May manage the development of new products for CroíValve that meet patient, customer and business needs.

May serve as the Project Lead on one or more project, developing plans and goals for the project which meet the overall company goals.

Individually or in support role, develop project plans, timelines, budget and resource requirements and communicate these to stakeholders.

Demonstrate collaborative leadership, being able to collaborate across multiple functions, beyond R&D.

Manage external vendors / partners as necessary to support product development activities.

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 design and develops best in class, reliable medical devices.

Ensures that test plans and testing executed aligns with regulatory requirements.

Prepares regulatory submission-ready documentation for the FDA and other regulatory bodies.

May support clinical activities including limited clinical case support.

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.

Manage and develop Senior and R&D engineers.

Build trust and strong relationships with other departments to help get work done most efficiently for the business.

Be a person staff can come to for help and problem solving.

Creates clear goals and objectives for direct reports and ensures that staff are clear on expectations.

Supports staff in creating their development plans, and creates succession plans for staff to allow for employee progression.

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 to ensure projects can progress as planned.

Promotes best practice in relation to capture, analysis and communication of data to feed into technical decision-making across the company.

Risk based problem solving to ensure highest risk items in the project are addressed.

Project Management : While this is predominantly a People Leader role, the individual may take on Project Leadership roles as the need arises.

Thus strong project management skills are required.

Initiative : Manages the work of others and self under limited supervision and take initiative in communicating and alignment of project activities with stakeholders.

Identify knowledge / experience gaps that exist within team and takes actions to address to ensure optimal performance.

Is seen as a leader within the R&D organisation.

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.

Proactivecommunication to ensure any potential significant issues are communicated upfront.

Demonstrates collaborative leadership, being able to collaborate across multiple functions, beyond R&D.

Develops a positive team culture to ensure a high-performance engineering team, where the sum of the team output is greater than their individual parts.

Manages external vendors / partners as necessary to support product development activities.

IP : Actively supports team innovation through regular contribution of disclosures to company's patent portfolio, and maintenance of the IP portfolio.

Education and Experience

Minimum of Bachelor's degree in Mechanical or Biomedical Engineering, or related field

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.

The projects should incorporate new product development (preferably in Class III cardiovascular devices).

Good leadership and project management skills with the ability and willingness to effectively build and manage a small team.

Demonstrated experience in people mentoring and development.

Deep and current understanding of FDA and ISO 13485 requirements, with the ability to interpret these requirements and implement them into new product development.

Experience in design, verification, and process validation processes.

Broad knowledge of materials and manufacturing processes applicable to medical device industry is desirable.

Experience working with sub-contract manufacturers / suppliers / test facilities, including integration of their activities into the product development activities.

Previous experience of the planning and preparation of regulatory submission to agencies, competent authorities and / or Notified bodies.

Excellent communication, organisational and time management skills.

Good problem-solving mindset.

Strong verbal and written communication skills.

At ease in start-up environment and effectiveness to deliver in low-structured environments.

Demonstrated ability to communicate within a team / company structure and to achieve project and company objectives.

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