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R&D Program Manager - Hybrid

CroíValve

CroíValve

Operations
Dublin, Ireland
Posted on Monday, January 15, 2024

R&D Program Manager

CroíValve is developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR). We have an opening in our R&D team for a talented and motivated individual to join us to help lead our product development efforts through initial human studies towards commercialisation.

Candidates should be motivated to work in a startup environment at the leading edge of novel product development. Previous experience in a startup environment and previous experience of structural heart or closely related devices is preferred, but not essential.

This role is site based in our Dublin office. Occasional work from home is facilitated bit the role is predominantly on site

The Role

Responsible for Project Management of Projects within the R&D/Product Development functions encompassing all project activities leading to clinical and commercial approval.

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:

Project Management

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

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

  • Develop project plans, timelines, budget and resource requirements and communicate these to stakeholders.

  • Translate project plans and goals into work package ownership areas for team members and align with other management team members on individual goals and work package ownership for staff to ensure project goals are met.

  • Strong project management skills to lead cross functional projects, ensuring on time and on budget delivery. Creative approaches to reducing project risks and shortening timelines while delivering business objectives.

  • Provide support to team members in the execution of the work and delivery of project deliverables as the product advances through the design development cycle.

  • Communicate 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.

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

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

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

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.

People Leadership

  • Coach and mentor more Senior and R&D engineers, without direct supervisory authority.

  • While this is predominantly a project leadership role, this role may take supervisory/management responsibility of a small number of more junior engineers or technicians

Essential Requirements

  • 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.

  • 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: Extensive project management skills. Is capable of developing project plans, timelines, budget and resource requirements and communicating these to stakeholders. Translates project plans and goals into work package ownership areas for team members and align with other management team members on individual goals and work package ownership for staff to ensure project goals are met. Uses best-in-class tools to effectively identify, track and communicate progress and project risks across all internal and external stakeholders and ensures such risks are effectively controlled with support of other management team members. Develops creative approaches to reducing project risks and shortening timelines while delivering business objectives. Provide support to team members in the execution of the work and delivery of project deliverables as the product advances through the design development cycle. Ideally is a certified project manager, although this is not a requirement.

  • 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.

  • 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. Coach and mentor more Senior and R&D engineers, without direct supervisory authority. While this is predominantly a project leadership role, this role may take supervisory/management responsibility of a small number of more junior engineers or technicians.

  • 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. Proactive communication 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.

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

  • Project management skills - capable of operating and liaison at all levels including managerial, project and technical. Proven track-record in planning and resource management to meet defined project goals. Experience with processes to identify and control risks within the project. Ideally PMP or Prince 2 certified or holds similar qualification.

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

  • In depth knowledge of the EU Medical Device Regulation and MEDDEV guidance documents.

  • Experience in design, verification, and process validation processes.

  • Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems.

  • 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.

  • Experience of preparing technical documentation for design development/design control and to support submissions.

  • Excellent communication, organisational and time management skills.

  • Good problem-solving mindset.

  • 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 without direct supervisory authority.

  • 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.

Availability to travel is required.

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.

Linda Macken