Senior Manufacturing Engineer for CTI

ZEISS Group is a pioneering company with over 180 years in business, focused on innovation and technology for a sustainable future. They are seeking a Senior Manufacturing Engineer to lead new product development and sustain engineering initiatives in the medical device sector, specifically for cataract surgery solutions.

Responsibilities:

• Strategically manage and prioritize multiple concurrent projects and objectives, ensuring optimal allocation of resources and alignment with organizational goals
• Lead and facilitate design reviews, providing expert guidance across cross-functional teams (R&D, QA, OPS) to drive innovation and ensure compliance with regulatory standards
• Identify, champion, and implement process and procedural improvements to enhance manufacturing efficiency, product quality, and regulatory compliance
• Promote and embed lean manufacturing principles throughout the organization, driving continuous improvement and operational excellence
• Oversee the creation and maintenance of comprehensive product documentation, including component specifications, BOMs, CAD models and drawings, manufacturing instructions, and lot history records
• Direct the development, maintenance, and improvement of manufacturing equipment, tooling, and fixturing, ensuring reliability and scalability
• Author, execute, and supervise test protocols, analyze test data, and prepare detailed test reports to support validation and verification activities
• Lead process validation and equipment qualification efforts, ensuring all manufacturing processes meet regulatory and quality requirements
• Develop and maintain detailed project schedules, ensuring timely completion of milestones and deliverables
• Monitor manufacturing production yield and throughput; proactively identify issues and implement solutions to improve performance and minimize disruptions
• Establish, monitor, and evaluate key performance indicators for manufacturing processes, driving data-driven decision-making and continuous improvement
• Provide leadership and guidance to the assembly team, fostering a culture of quality, consistent manufacturing output, and high yields
• Travel periodically as required to support project deliverables, supplier audits, and organizational needs
• Initiate and oversee Document Change Orders and Nonconformance Material Reports activity; actively participate in Corrective and Preventive Actions as required

Requirements:

• Bachelor's or Master's degree in Mechanical Engineering preferred; certifications in leadership or medical device design are highly valued
• At least 7 years of engineering experience, ideally in regulated industries, with proven leadership in cross-functional teams and projects
• Strong interpersonal and collaborative skills; ability to mentor teams and communicate effectively; expert problem solver
• Skilled in SolidWorks CAD for complex fixture and tooling design, overseeing reviews and implementation across projects
• Deep knowledge of materials and processing methods; adept at optimizing for performance, manufacturability, and compliance
• Advanced training in GMP and ISO 13485; experienced in maintaining quality systems and driving improvement
• Lean Six Sigma expert with a history of leading successful process improvements and team training
• Proactive in identifying and solving technical and operational challenges, ensuring effective corrective actions across departments
• Significant clean room (CER) operations experience, including staff training and compliance leadership
• Physical requirements: Able to perform basic movements and tasks; comfortable with exposure to manufacturing materials