Senior Project Engineer

CSafe is seeking a Senior Project Engineer in Monroe, Ohio to join our world class global engineering team! In this role, you will provide continuous project management monitoring and support on large or complex engineering projects to ensure they are well planned, controlled and executed within the agreed project timeline and budget. Come join our growing industry and build your career with us!

CSafe offers the most comprehensive temperature-management solutions for pharmaceutical cold chain shipping needs around the world to ensure patients receive life enhancing products. With a "patient-centered" focus, deep industry expertise and commitment to innovation, CSafe continues to deliver industry-leading solutions across multiple business segments. Our team operates with curiosity, humility, accountability, and entrepreneurial spirit to deliver on our vision and mission.

Essential Functions:

• Lead the planning, execution, and delivery of NPD & Lifecycle Management engineering projects, ensuring they meet quality, time, and budget constraints
• Own, Develop, and implement Project Charters, Project Plans, Schedules, Quote and Budgets, adjusting as necessary based on business demands or changes
• Ensure all Product Requirements are clearly defined and communicated from Product Management team to the Global Engineering team.
• Coordinate with cross-functional teams, including engineering, product, manufacturing, supply chain and quality, to ensure project timelines are maintained and milestones are met
• Problem solve complex design or project related challenges to a successful outcome
• Perform risk assessments (FMEA) to identify potential project obstacles and devise mitigation strategies to ensure project success
• Ensure proper Design for Manufacture and Design for Quality analysis have been performed and ensure coordination and execution of technical transfer to Operations, Quality, and Production teams.
• Oversee the design and development of engineering solutions, ensuring they comply with industry standards and project specifications
• Facilitate communication between project stakeholders, including internal and external customers, contractors, and engineering team members, to ensure clear understanding of project objectives and progress
• Manage technical communication & documentation, such as design requirements, test plans, technical reports, and specifications sheets, ensuring accuracy and compliance
• Prepare and present Executive level project summaries identifying key project milestones, timelines, and risk/risk mitigation decision points.
• Investigate and apply innovative technologies or methodologies to improve project outcomes, efficiency, or sustainability.
• Lead and support in all engineering activities associated with product development, design review, validation, production transfer and product launch

Qualifications and Experiences:

• Bachelor's or Master's Degree in Engineering relevant field, Aeronautical Engineering, Biomedical Engineering preferred
• Project Management Professional (PMP) certified preferred
• 5+ years' experience in similar role in highly regulated industry
• Experience of both mechanical & electrical systems and their integration into one product would be preferred
• Manage multiple projects using strong time management practices and project planning tools
• Background in coordinating multidisciplinary global teams and suppliers, ensuring project milestones are met within budget and time constraints
• Possess analytical thinking skills and reasoning skills to overcome complex challenges
• Strong interpersonal skills, especially around both written and verbal communication
• Substantial experience in project management, demonstrating proficiency in leading, tracking and communicating complex projects from conception to completion
• Working knowledge and training in advanced project management tools and methodologies as well as risk analysis and management
• Experience with in a highly regulated industry such as Aerospace, Pharmaceutical, or Medical Device would be beneficial
• Knowledge of low voltage electrical components and subsystems including control systems, power management, refrigeration system, battery management…