Project Manager - Zavation Medical Products
Flowood, MS 39232
About the Job
The Project Manager will work within Manufacturing and Operations to provide oversight in various aspects of our production processes, ensuring efficiency, quality, and continuous improvement. This position will require strong project management experience in design and development projects within an FDA regulated industry, as well as strong knowledge of design control processes, industrialization, and supply chain concepts. The right candidate for this role will be accustomed to working with cross functional teams with multiple departments, evaluating project risks and mitigations, task management, analysis, and reporting metrics within an FDA regulated environment.
Responsibilities:
- Understand interdependencies between technology, operations, and business needs
- Contribute to innovation and process excellence by always having the customer in mind and understanding the industry, environment, and challenges
- Coaching and training of the project team throughout execution of projects.
- Introducing PM processes and toolkits for the projects which enables team to execute the projects on time, securing both scope and quality.
- Establishing of the project timeline, tasks, and risk analysis to officially start a project
- Planning of available resources according to the project plan
- Execution of projects according to the project roadmap
- Coordination of the project team with the various disciplines from all the involved departments (Operations, Marketing, Quality & Regulatory)
- Driving internal and external teams to execute on tasks and deliverables
- Holding team members accountable to project commitments
- Ensure the project progress: milestones, overall timeline, budget and cost
- Organization and leadership of project and review meetings on a regular basis and reporting
- Identifying potential plan deviations and preparing impact analysis for key stakeholders
- Facilitate escalation and risk mitigation actions as necessary
- Ensuring compliance to regulatory requirements for medical devices during project process
- Assisting in ensuring complete project and product documentation from project start to launch
- Close collaboration within cross functional teams
- Bachelor’s degree in science or engineering related discipline.
- Well-founded knowledge in project management, PMP certification or similar desired
- Experience in a highly regulated industry (preferably medical devices)
- Strong verbal and written communication skills
- Motivating leadership qualities
- Goal oriented, transformational, and transactional leadership skills,
- Adept problem-solving skills
- Familiarity with LEAN/Six Sigma problem solving, tools, and methodologies
- Knowledge of FDA regulations and ISO 13485 for medical devices desirable
- Experience with Dot Compliance/Salesforce desirable
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Source : Zavation Medical Products