Research and Development Program Manager

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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 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 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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