Job Title: R&D Program Manager
As a key member of our organization, you will be responsible for managing the development of new products that meet patient, customer and business needs. You will serve as the Project Lead on one or more projects, developing plans and goals that meet the overall company objectives.
Key Responsibilities:
* 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.
* 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.
* 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
* 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
Requirements:
* 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.