A minimum of 3 years’ experience and a proven track record in:
o Applying project management tools to manage Product Development Projects
o Applying project management tools to manage Engineering Projects
o Building, managing, and maintaining business partnerships.
o Applying knowledge of ISO standards and FDA Design Control regulations
- Experience in development of complex sophisticated software controlled electromechanical medical devices with verification & validation activities is a plus.
- Experience in outsourced medical device manufacturing, manufacturing technologies and process development is a plus.
- BS in engineering or technical field with 3+ years of product development (medical device engineering) and 3+ years of applicable project management experience in medical devices, healthcare, or pharma development environment.
- Possesses interpersonal skills to negotiate and reconcile differences, while optimising overall business goals.
- Excellent written and verbal communications skills with strong competency in MS Office tools and Project management applications.
- Certification in Process Excellence (Green Belt or Black Belt) or project management certification PMP is a plus.