Research and Development Program Manager
Our Client, a medical device manufacturer, is currently looking for a Research & Development Program Manager to join their organization. This a new role and the perfect opportunity for you to make your mark in an innovative, growing organization.
The successful candidate will :
- Manage the development of new products to 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 objectives.
- Develop project plans, timelines, and resource requirements and communicate these to relevant stakeholders.
- Translate project plans for team members and align with other management team members on individual goals for staff to ensure project goals are met.
- Have a creative approach 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.
- Develop a positive team culture to ensure a high performing Research and Development team.
- Manage external vendors / partners, as necessary, to support product development activities.
- Ensure that test plans and testing execution aligns with regulatory requirements.
- Maintain product files and other relevant documentation to comply with quality standards.
- Support clinical activities including limited clinical case support and post-market surveillance.
While this is predominantly a project leadership role, this role may take supervisory / management responsibility of a small number of engineers and / or technicians.
Qualifications, Skills and Experience Required
Minimum of a Bachelor’s of Arts Product Design or Science degree in Mechanical or Biomedical Engineering, or related field.Minimum of 3 years in a similar role in medical device product development, preferably in Class 1 products.Familiarity with all phases of product development and research project developments.Project management skills – capable of operating and liaising at all levels of the business.Proven track-record in planning and resource management to meet defined project goals.Experience with design packages e.g. AutoCAD and SolidWorksCurrent understanding of FDA, MDR and EN : ISO 13485 : 2016 requirements, with the ability to interpret these requirements and implement them into new product development.Experience of preparing technical documentation for design development / design control.A 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.A working knowledge of polymer materials would be an advantage.