Senior Manufacturing Engineer for CTI

ZEISS Group•Remote - USA NV, NV

8d•Onsite

About The Position

Join ZEISS and help shape the future of cataract surgery through cutting-edge medical device innovation. This role is ideal for engineers who thrive on ownership, technical depth, and cross-functional leadership. In this role, you will contribute to the next-generation surgical solutions such as the ZEISS miLOOP and ZEISS MICOR. Join a rare engineering environment where innovation moves fast and scale matters. The Reno team combines the best of two worlds: a startup mindset empowered by the resources, funding and stability of ZEISS. You will serve as the project leader and chief technical authority for new product development and sustaining engineering initiatives, collaborating closely with R&D, Operations, and Quality Management teams.

Requirements

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.

Nice To Haves

Bachelor's or Master’s degree in Mechanical Engineering preferred; certifications in leadership or medical device design are highly valued.

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.