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 needsContribute to innovation and process excellence by always having the customer in mind and understanding the industry, environment, and challengesCoaching 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 projectPlanning of available resources according to the project planExecution of projects according to the project roadmapCoordination 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 deliverablesHolding team members accountable to project commitmentsEnsure the project progress: milestones, overall timeline, budget and costOrganization and leadership of project and review meetings on a regular basis and reportingIdentifying potential plan deviations and preparing impact analysis for key stakeholdersFacilitate escalation and risk mitigation actions as necessaryEnsuring compliance to regulatory requirements for medical devices during project processAssisting in ensuring complete project and product documentation from project start to launchClose collaboration within cross functional teamsRequirements:Bachelor's degree in science or engineering related discipline. Well-founded knowledge in project management, PMP certification or similar desiredExperience in a highly regulated industry (preferably medical devices)Strong verbal and written communication skillsMotivating leadership qualitiesGoal oriented, transformational, and transactional leadership skills, Adept problem-solving skillsFamiliarity with LEAN/Six Sigma problem solving, tools, and methodologiesKnowledge of FDA regulations and ISO 13485 for medical devices desirableExperience with Dot Compliance/Salesforce desirableExperience with SmartSheets desirable