R&D Manager

R&D Manager

Our client, a high-potential medical device start-up, is currently seeking an R&D Manager to join their team. Reporting to the VP of R&D, the R&D Manager will be responsible for the management of people and departmental activities within the R&D/Product Development functions, encompassing all activities leading to clinical and commercial approval.

Role/Responsibilities:

• 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 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 reflect the company values.
• 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.
• 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.
• Keep abreast of technological changes within the therapeutic 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.
• May manage the development of new products that meet patient, customer, and business needs.
• May serve as the Project Lead on one or more projects, developing plans and goals for the project which meet the overall company goals.
• Individually or in a 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.

• 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 a 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 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 in the planning and preparation of regulatory submissions to agencies, competent authorities, and/or Notified bodies.
• Excellent communication, organizational, and time management skills.
• Good problem-solving mindset.
• Strong verbal and written communication skills.
• At ease in a start-up environment and effective in delivering in low-structured environments.
• Demonstrated ability to communicate within a team/company structure and to achieve project and company objectives.