The Project Manager will lead and deliver global new projects through the JJSV Product Delivery Process and will be accountable for guiding the cross-functional teams to ensure strategic alignment and execution of the project deliverables, on schedule, within budget, and to the required quality / reliability standards. The Project Manager will apply best practices and tools to deliver new products consistent with business’s strategy and objectives. They are a technically strong individual who works directly with the Technical Leads, Functional Managers and Business Leaders to identify and coordinate resolution of technical and project risks. The Project Manger provides timely and effective communication of project progress, advocates for resource and budgetary needs, and employs a leadership style that inspires teamwork, high standards, compliance and overall success in project results for the benefit of the customer and the company.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES
- Responsible for and compliance with applicable Corporate and Divisional Policies and procedures.
- Develop and ensure all deliverables (project and technical) are well understood by the project core team.
- Lead project team to appropriately challenge project assumptions and thoroughly identify the project and technical risks.
- Prepare project schedule, ensuring timing estimates from the cross-functional team are accurate and appropriately challenged, including buffers to mitigate risks.
- Organize and deliver presentations to management, including the Global New Product Process at stage gate meetings.
- Execute high quality, integrated cross-functional project plans including development of project charter, schedule, milestones, budget, risks, issues and resources needed.
- Be the primary point of contact for the project and interface with Technical Leader on technical issues, Functional Manager on resource issues and Executive Sponsor on project issues.
- Facilitate cross-functional communication between R&D, Marketing, Operations, Quality Assurance and Clinical/ Regulatory organizations.
- Lead project team meetings, develops and manages agenda, minutes, and follow up action items.
- Resolve issues, conflicts and project bottlenecks as they arise, negotiating effectively with others. Drive recovery effort so issues do not impact overall schedule.
- Ensure projects run in compliance with Design Control Regulations.
- Supervise the activities of other lower-level personnel.
BS in Engineering or Science fields is required.
Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
8 + years of professional experience with emphasis in Project Management in a regulated environment (preferably medical devices) is required.
A technical background in health care, laboratory diagnostics, medical devices, or pharmaceutical companies.
Minimum of 3 years of experience in R&D new product development in technology-driven manufacturing industry is required.
• A career history marked by a consistent series of significant contributions and accomplishments.
• Interacts well with diverse groups across a division and maintains strong working relationships with internal and external collaborators.
5+ years of significant engineering and/or operational experience.
• Has managed technical core team members and groups of engineers, either by direct report or by influence.
• Possesses interpersonal skills to negotiate and reconcile differences, while optimizing overall organizational goals.
• Understanding and management of procurement & contracting processes
A proven track record of successfully delivering new products through the entire development lifecycle, from concept through launch.
Practical knowledge of each of the following:
• ISO 13485
• FDA / MDD / CE
• IEC 62304 / 62366
• Design Controls / Design History File
• Requirements Definition
• ISO 14971 / Risk Management
• Validation & Verification