Project Manager MDR Boston Area Key Responsibilities: Responsible for leading the MDR project, representing the site on various MDR forums. Provide regular updates on the progress within the site and to wider MDR program. Develop and maintain detailed Microsoft project plans for impacted product families. Assure multi-functional alignment in development and validation activities for manufacturing processes. Provides direction and technical support for MDR in the development and implementation of manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation. Facilitate manufacturability of new product variants under MDR project from concept through end-to-end process qualification by developing close working relationships to key business partners. Support updating procedures, manufacturing specifications, bills, routes and travelers for product & process changes in the PLM system. Provides direction in supporting the needs of manufacturing areas in terms of meeting the requirements for quality standards, compliant documentation, capacity and product availability. Champions a collaborative, high-performing team culture based on achieving outstanding results by supporting and developing the MDR team. Ensure compliance with all FDA, ISO, quality, safety and environmental regulations. Qualifications Education: Bachelor of Science from an accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering or a related degree is required. Experience and Skills Required: Five (5) years of engineering experience. Project management training and hands on experience. Process validation experience. Experience in a Medical Device and/or regulated manufacturing work environment. Ability to lead in a team-based manufacturing environment. Ability to collaborate with all levels of management in a multi-functional team. Passion to develop and champion innovation, creativity and collaboration. Persuasive communication and interpersonal skills. Knowledge of Microsoft Office