[Remote] Senior Manufacturing Engineer for CTI

Note: The job is a remote job and is open to candidates in USA. 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.ResponsibilitiesStrategically manage and prioritize multiple concurrent projects and objectives, ensuring optimal allocation of resources and alignment with organizational goalsLead and facilitate design reviews, providing expert guidance across cross-functional teams (R&D, QA, OPS) to drive innovation and ensure compliance with regulatory standardsIdentify, champion, and implement process and procedural improvements to enhance manufacturing efficiency, product quality, and regulatory compliancePromote and embed lean manufacturing principles throughout the organization, driving continuous improvement and operational excellenceOversee the creation and maintenance of comprehensive product documentation, including component specifications, BOMs, CAD models and drawings, manufacturing instructions, and lot history recordsDirect the development, maintenance, and improvement of manufacturing equipment, tooling, and fixturing, ensuring reliability and scalabilityAuthor, execute, and supervise test protocols, analyze test data, and prepare detailed test reports to support validation and verification activitiesLead process validation and equipment qualification efforts, ensuring all manufacturing processes meet regulatory and quality requirementsDevelop and maintain detailed project schedules, ensuring timely completion of milestones and deliverablesMonitor manufacturing production yield and throughput; proactively identify issues and implement solutions to improve performance and minimize disruptionsEstablish, monitor, and evaluate key performance indicators for manufacturing processes, driving data-driven decision-making and continuous improvementProvide leadership and guidance to the assembly team, fostering a culture of quality, consistent manufacturing output, and high yieldsTravel periodically as required to support project deliverables, supplier audits, and organizational needsInitiate and oversee Document Change Orders and Nonconformance Material Reports activity; actively participate in Corrective and Preventive Actions as requiredSkillsBachelor's or Master's degree in Mechanical Engineering preferred; certifications in leadership or medical device design are highly valuedAt least 7 years of engineering experience, ideally in regulated industries, with proven leadership in cross-functional teams and projectsStrong interpersonal and collaborative skills; ability to mentor teams and communicate effectively; expert problem solverSkilled in SolidWorks CAD for complex fixture and tooling design, overseeing reviews and implementation across projectsDeep knowledge of materials and processing methods; adept at optimizing for performance, manufacturability, and complianceAdvanced training in GMP and ISO 13485; experienced in maintaining quality systems and driving improvementLean Six Sigma expert with a history of leading successful process improvements and team trainingProactive in identifying and solving technical and operational challenges, ensuring effective corrective actions across departmentsSignificant clean room (CER) operations experience, including staff training and compliance leadershipPhysical requirements: Able to perform basic movements and tasks; comfortable with exposure to manufacturing materialsBenefitsMedicalVisionDental401k MatchingEmployee Assistance ProgramsPaid time offCompany OverviewZeiss is a manufacturer of optical systems, industrial measurements, and medical devices. It was founded in 1846, and is headquartered in Oberkochen, Baden-Wurttemberg, DEU, with a workforce of 10001+ employees. Its website is http://www.zeiss.com.Company H1B SponsorshipZEISS Group has a track record of offering H1B sponsorships, with 1 in 2026, 2 in 2025, 3 in 2024, 1 in 2023, 6 in 2021. Please note that this does not guarantee sponsorship for this specific role.