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 is 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 projects, 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 SolidWorks.
* 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.
* Experience of preparing technical documentation for design development/design control.
* A 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.
* A working knowledge of polymer materials would be an advantage.
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