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:
1. Manage the development of new products to meet patient, customer and business needs.
2. Serve as the Project Lead on one or more project, developing plans and goals for the project which meet the overall company objectives.
3. Develop project plans, timelines, and resource requirements and communicate these to relevant stakeholders.
4. Translate project plans for team members and align with other management team members on individual goals for staff to ensure project goals are met.
5. Have a creative approach to reducing project risks and shortening timelines while delivering business objectives.
6. 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.
7. 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.
8. Develop a positive team culture to ensure a high performing Research and Development team.
9. Manage external vendors/partners, as necessary, to support product development activities.
10. Ensure that test plans and testing execution aligns with regulatory requirements.
11. Maintain product files and other relevant documentation to comply with quality standards.
12. 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
13. Minimum of a Bachelor's of Arts Product Design or Science degree in Mechanical or Biomedical Engineering, or related field.
14. Minimum of 3 years in a similar role in medical device product development, preferably in Class 1 products.
15. Familiarity with all phases of product development and research project developments.
16. Project management skills – capable of operating and liaising at all levels of the business.
17. Proven track-record in planning and resource management to meet defined project goals.
18. Experience with design packages e.g. AutoCAD and SolidWorks
19. Current understanding of FDA, MDR and EN:ISO 13485:2016 requirements, with the ability to interpret these requirements and implement them into new product development.
20. Experience of preparing technical documentation for design development/design control.
21. A broad knowledge of materials and manufacturing processes applicable to medical device industry is desirable.
22. Experience working with sub-contract manufacturers/suppliers/test facilities, including integration of their activities into the product development activities.
23. A working knowledge of polymer materials would be an advantage.