R&D Program Manager

Life Science Recruitment; Dublin; On-site; EUR 60,000 - 85,000; Full time

Job summary

A leading recruitment agency in Dublin is seeking an experienced R&D Program Manager to oversee project management within R&D/Product Development. The ideal candidate will have extensive experience in medical device product development, regulatory knowledge, and excellent project management skills. This role requires strong leadership abilities and the capacity to manage teams effectively within a start-up environment.

Qualifications

• Minimum of seven years in a similar role in medical device product development.
• Experience in project management of technical projects across R&D.
• Deep understanding of FDA and ISO 13485 requirements.

Responsibilities

• Manage the development of new products to meet customer needs.
• Serve as Project Lead on projects, developing plans that align with company goals.
• Communicate updates on project progress and manage stakeholder expectations.

Skills

Project management skills

Problem-solving mindset

Communication skills

Leadership abilities

Knowledge of FDA requirements

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

GMP

ISO 13485

design validation processes

Job description

R&D Program Manager

Our client, a high potential start-up, currently seeks an R&D Program Manager to join their team. Reporting to the VP of R&D, the R&D Program Manager will be responsible for Project Management of Projects within the R&D/Product Development functions, encompassing all project activities leading to clinical and commercial approval.

Role/Responsibilities

• Manage the development of new products that meet patient, customer, and business needs.
• Serve as the Project Lead on one or more projects, 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.
• 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 align 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 Company's IP portfolio.
• 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.

Skills/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.
• 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.
• 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 the 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 submissions to agencies, competent authorities, and/or Notified bodies.
• Experience of preparing technical documentation for design development/design control and to support submissions.
• Excellent communication, organizational, 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.
• Strong verbal and written communication skills.
• At ease in a 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.