Overview
R&D Program Manager
Our client, a high potential start up, 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 that align with overall company goals.
* Develop project plans, timelines, budgets 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.
* Apply strong project management skills to lead cross-functional projects, ensuring on-time and on-budget delivery. Use creative approaches to reduce project risks and shorten timelines while delivering business objectives.
* Provide support to team members in the execution of the work and delivery of project deliverables as the product progresses 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 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 processes in the design and development of the product to ensure reliability and high quality.
* Ensure that test plans and testing activities 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 senior and R&D engineers without direct supervisory authority.
* While predominantly a project leadership role, this position may take supervisory/management responsibility for 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 of technical projects across R&D and Manufacturing. Projects should include new product development (preferably in Class III cardiovascular devices).
* Project management skills capable of operating at all levels (managerial, project, technical). Proven track record in planning and resource management to meet defined project goals. Experience with risk identification and control. PMP or Prince 2 certification or equivalent is preferred.
* Deep and current understanding of FDA and ISO 13485 requirements, with ability to interpret and implement them in new product development.
* In-depth knowledge of EU Medical Device Regulation and MEDDEV guidance documents.
* Experience in design, verification, and process validation processes.
* Prior experience with 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 product development.
* Experience planning and preparing regulatory submissions to agencies and Notified Bodies.
* Experience preparing technical documentation for design development/design control and submissions.
* Excellent communication, organizational and time management skills.
* Good problem-solving mindset, leadership and project management abilities with the capacity to build and manage a small team and mentor others without direct supervisory authority.
* Strong verbal and written communication skills.
* Comfort operating in a start-up environment and the ability to deliver in low-structure environments.
* Demonstrated ability to communicate within a team/company structure to achieve project and company objectives.
For further information please contact James Cassidy james.cassidy@lifescience.ie or call in confidence 086 0204322
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