Project Manager

Main Responsibilities:

• Provides leadership and centralised 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.

• Manages and is responsible for all phases of project execution including stage gate reviews, design reviews, etc.

• Leads the project team members in using established PM tools and techniques to stay within authorized budget limits and achieve the overall project and organizational objectives.

• Competent in conducting risk assessments for technical and project related issues and developing mitigation plans to ensure project schedule and costs are maintained.

• Innovator and forward thinker. Leads and contributes to the development of GDE organisation thru innovative thinking and application of technical knowledge.

• Develops methods, procedures, and metrics for projects (scope, schedule, quality, and cost) and reporting. Monitors and controls implementation plan in accordance with defined scope.

• Responsible for the successful execution of significant technical projects. Through proper planning, ensures that scope, schedule, cost, and customer expectations are met. Maintains a clear focus on life cycle costs.

• A technical / engineering background in Medical Device product development and sustaining engineering within the medical device sector.

• Fosters an environment of innovation in others, integrating experiences from multiple disciplines to develop solutions that meet the business objectives.

• An understanding of medical device regulations including FDA standard 21 CFR Parts 820, design controls, ISO13485, regulatory audits and international environmental regulations. Experience and track record of success in the development of 510K/PMA regulated medical products required.

Job Requirements:

• 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 development of complex sterile disposable medical devices including plastic injection molding, extrusion and assembly methods is a plus.

• Experience in outsourced medical device manufacturing, manufacturing technologies and process development is a plus.

• BS in engineering or technical field with 5+ years of product development (medical device engineering) and 5+ 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.

1. • Certification in Process Excellence (Green Belt or Black Belt) or project management certification PMP is a plus.