- Provides leadership and centralized management for the planning, development and execution of technical projects to achieve critical strategic business objectives. Manages multiple, often concurrent projects and consistently meets expectations.
- Competent in making difficult decisions regarding priorities among projects / programs while ensuring the buy in of teams and leaders
- Competent in managing external vendors, including the procurement, process development & qualification of custom equipment.
- Competent in conducting risk assessments for technical and project related issues and developing mitigation plans to ensure project schedule and costs are maintained
- Responsible for the successful execution of significant technical projects. Develops methods, procedures and metrics for projects (scope, schedule, quality and cost) and reporting. Monitors and controls implementation plan in accordance with defined scope
- A technical / engineering background in new product or process development within the medical device / pharma sector.
- A minimum of 5 years experience and a proven track record in:
o Applying project management tools to manage New Product Development Programs in the medical device industry
o Managing external vendors, including the procurement, process development & qualification of custom equipment.
o Building, managing and maintaining business partnerships
o Applying knowledge of ISO standards and FDA Design Control regulations
- Experience in development and qualification of injection mould tooling, automation or other custom-built equipment is a plus.
- Experience in outsourced medical device manufacturing, manufacturing technologies and process development is a plus
- Possesses interpersonal skills to negotiate and reconcile differences, while optimizing 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.