Manufacturing Engineer at Edwards… · USA -…

Summary: Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Manufacturing Engineer I position offers a unique career opportunity to contribute to highly visible products and advance manufacturing excellence by supporting pilot production and driving continuous improvement within a regulated medical device environment. Responsibilities: - Contribute as a key member of the Pilot Operations team, supporting programs that advance new medical devices from development through commercialization and scale‑up - Build strong technical and process knowledge to support rapid product development cycles, process stabilization, and successful technology transfer to global manufacturing sites - Develop, implement, and support Manufacturing Execution System (MES) capabilities for products within the Pilot pipeline, ensuring readiness for commercialization and scale - Improve manufacturing processes using engineering methods such as Lean fundamentals and basic statistical analysis to drive continuous improvement - Design, execute, and document experiments and tests, including writing protocols, analyzing results, and developing reports to qualify and validate manufacturing processes - Analyze and help resolve basic manufacturing and compliance issues, including CAPA activities, non‑conformances, and audit observations, in alignment with quality and regulatory requirements - Create and maintain training materials and manufacturing documentation, including work instructions, to support effective knowledge transfer to production teams - Develop and manage project plans using standard project management tools, including timelines and risk analyses, to ensure deliverables meet customer and business expectations - Identify opportunities to redesign basic equipment, tools, fixtures, or processes to improve manufacturing performance, reliability, and scalability - Provide day‑to‑day manufacturing support by guiding technicians through testing activities, training and coaching technicians, providing feedback, and coordinating technician work - Support Pilot Operations leadership with additional responsibilities and tasks as needed to meet evolving business and program needs Required Qualifications: - Bachelor's Degree in Engineering or Scientific field Preferred Qualifications: - Demonstrated proficiency with standard computer tools, including the Microsoft Office Suite (MS Project experience preferred; CAD experience a plus, if applicable) - Strong foundational documentation, written and verbal communication, and interpersonal skills - Basic understanding of statistical techniques and their application in manufacturing or engineering environments - Prior experience in Class III medical device manufacturing (preferred) - Solid understanding of engineering principles, theories, and concepts relevant to the role - Effective problem‑solving, organizational, analytical, and critical‑thinking skills - Working knowledge of manufacturing processes and equipment used within assigned areas - Knowledge of and adherence to Edwards Environmental Health & Safety (EHS) and Quality guidelines, particularly within regulated cleanroom medical device manufacturing environments - Strong attention to detail and commitment to accuracy - Ability to interact professionally and effectively with employees at all organizational levels - Ability to manage competing priorities in a fast‑paced, dynamic environment - Proven ability to work collaboratively in a team environment, including with supervisors, peers, cross‑functional partners, and external vendors as needed - Ability to build and maintain strong, stable internal working relationships - Commitment to complying with all company policies and requirements, including safety, environmental, quality, and health protocols, and taking appropriate actions to prevent injury, protect the environment, and prevent pollution within their scope of influence Required Skills: Manufacturing Execution System (MES), Lean fundamentals, Statistical analysis, Experiment design, Manufacturing process validation, CAPA, Microsoft Office Suite, MS Project, CAD, Class III medical device manufacturing, Engineering principles, Manufacturing processes, Environmental Health & Safety (EHS), Quality guidelines, Cleanroom manufacturing, Analytical skills, Project management Benefits: Competitive salaries, Performance-based incentives, A wide variety of benefits programs