STEM Recruitment Partners are collaborating with a leading client to offer a 12-month contract for an R&D Project Manager.
€75-85/hour DOE Role Overview: Reporting to the Senior Director of Device Engineering, the Project Manager will lead technical projects, including planning, scheduling, budget management, and resource management.
This role involves managing change control and stage gate projects in alignment with departmental SOPs across cross-functional groups.
As a project management expert, you will ensure all activities for product development projects adhere to design controls and meet technical quality, reliability, schedule, and cost requirements.
Main Responsibilities: Provide leadership and centralized management for the planning, development, and execution of technical projects to achieve critical strategic business objectives.
Manage multiple, concurrent projects, consistently meeting expectations.
Make difficult decisions regarding project priorities, ensuring team and leader buy-in.
Oversee all phases of project execution, including stage gate reviews and design reviews.
Lead project team members in using established PM tools and techniques to stay within budget and achieve project and organizational objectives.
Conduct risk assessments for technical and project-related issues, developing mitigation plans to maintain project schedules and costs.
Innovate and contribute to the development of the organization through the application of technical knowledge.
Develop methods, procedures, and metrics for projects (scope, schedule, quality, and cost) and reporting.
Monitor and control implementation plans according to defined scope.
Ensure the successful execution of significant technical projects, maintaining a clear focus on life cycle costs.
Possess a technical/engineering background in medical device product development and sustaining engineering within the medical device sector.
Foster an environment of innovation, integrating experiences from multiple disciplines to meet business objectives.
Understand medical device regulations, including FDA standard 21 CFR Parts 820, design controls, ISO13485, regulatory audits, and international environmental regulations.
Have a track record of success in developing 510K/PMA regulated medical products.
Job Requirements: A minimum of 8 years experience with a proven track record in: Applying project management tools to manage product development projects.
Applying project management tools to manage engineering projects.
Building, managing, and maintaining business partnerships.
Applying knowledge of ISO standards and FDA Design Control regulations.
Experience in developing complex, sophisticated software-controlled electromechanical medical devices with verification & validation activities is a plus.
Experience in developing 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 a technical field with 8+ years of product development (medical device engineering) and 8+ years of applicable project management experience in medical devices, healthcare, or pharma development environments.
Possess interpersonal skills to negotiate and reconcile differences while optimizing overall business goals.
Excellent written and verbal communication 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.
Skills: Research and development medical devices product development