- Project Planning:
- Effectively lead, guide, manage, and mentor a team of internal and external cross functional resources to deliver the set project milestones to support the required regulatory submissions.
- Responsible for the planning and coordination of all project team activities, translating strategy into cross-functional integrated project plans.
- Prioritize the project tasks by identifying the critical path, remove any obstacles or barriers, resolve issues or conflicts to progress the project.
- Direct Project Management Staff:
- Works with EBD PM staff and other team members to ensure that project teams meet their objectives on time and on budget. Acts as an advisor to EBD PM staff, coaching on problem solving approaches, methods, tools and techniques. Mentors' members of the EBD PM staff.
- Risk Management:
- Anticipate and manage project risks and issues, and provide specific mitigation and corrective action strategies.
- Resource Management:
- Manage resources within a project team, when needed, negotiate with respective functional groups for the acquisition of required personnel for the project.
- Communication and Stakeholder Management:
- Facilitate project team meetings, set agendas, publish meeting minutes, follow-up on action items, and maintain required project documentation.
- Develop presentations and communicate project status against key project milestones and budget for a broad set of stakeholders.
- Facilitates communication across EBD functions and engage stakeholders to achieve solutions to critical issues. Influences the strategy and tactics throughout the course of product development.
- Budget Management:
- Define, monitor, and manage project budgets, including quarterly forecasting and monthly budget reporting.
- Assist, as needed, the respective functional team member with contracting process for outsourced activities including review and approval of the contract as necessary according to the approved project budget.
- Other duties as assigned:
- Lead ad-hoc projects and/or multidisciplinary task forces for ongoing development and/or refining of processes as needed
- Motivate and mentor the team to achieve set project objectives
- Thorough understanding of Project Management practices, principles, and tools for medical device/drug/consumer product development projects
- Good experience with Design Control, ISO 13485, ISO 14971 and other applicable standards
- Demonstrated project management skills in leading multi-disciplinary, multi-regional teams to meet project goals
- Knowledge across the entire product development process from concept phase through design and development, design transfer, regulatory submission and approval, and launch
- Expert knowledge of MS Excel, Outlook, PowerPoint, Word and proficient in MS Project
- Proven experience managing multiple projects and/or programs concurrently
- Demonstrated proficiency managing rapidly changing priorities and aggressive timelines
- Demonstrated ability to monitor, manage, and grow diverse external partnerships (CMO management)
- Experience as an advisor to senior management on project and portfolio issues
- Demonstrate strong interpersonal, leadership, self-starting, oral/written communication skills
- Demonstrate advanced skills as a team leader, motivator, and in conflict resolution
- Prior proven experience managing staff and direct reports
- Bachelor's degree in engineering, a Life Science or related discipline.
- Minimum of 10 years of relevant industry experience
- At least 7 years of Project Management experience
- Advanced degree in engineering, a Life Science or related discipline (MSc, PhD, PharmD).
- Experience in electromechanical / energy-based device development
- Good working knowledge of regulatory filing requirements as they pertain to medical device product development
- Professional Project Management related certification (PMP or similar)
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Director Project Management Energy Based Devices - Raleigh, United States - Merz North America
Description
As a Director, you'll play a pivotal role in bringing new products to the market to make a positive impact on our customers - to make them live better, feel better and look better. The Director will report to the VP, Head of Global PMO for Merz Aesthetics and works within the Global Project Management team. The Director will manage and oversee the internal and external coordination of projects to ensure effective project leadership and communication as well as timely and successful project completion.
Responsibilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)
