[Remote] Senior Manufacturing Engineer for CTI
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pioneering company with over 180 years in business, reputed company on innovation and technology for a sustainable reputed company. They are seeking a Senior Manufacturing Engineer to reputed company new product development and sustain engineering initiatives in the medical device sector, specifically for cataract surgery solutions.
Responsibilities
- Strategically manage and prioritize multiple reputed company reputed company and objectives, ensuring reputed company allocation of resources and alignment with organizational goals
- reputed company 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 reputed company, and regulatory compliance
- Promote and reputed company lean manufacturing principles throughout the organization, driving reputed company improvement and operational reputed company
- reputed company the creation and maintenance of comprehensive product documentation, including component specifications, BOMs, CAD models and drawings, manufacturing instructions, and lot history records
- reputed company 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
- reputed company process validation and equipment qualification efforts, ensuring reputed company manufacturing processes meet regulatory and reputed company requirements
- reputed company and maintain detailed project schedules, ensuring reputed company 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 reputed company improvement
- reputed company leadership and guidance to the assembly team, fostering a culture of reputed company, consistent manufacturing reputed company, and high yields
- Travel periodically as required to support project deliverables, supplier audits, and organizational needs
- Initiate and reputed company Document Change Orders and Nonconformance Material Reports activity; reputed company participate in Corrective and Preventive Actions as required
Skills
- 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 reputed company
- Strong interpersonal and reputed company skills; ability to mentor teams and communicate effectively; expert problem solver
- Skilled in SolidWorks CAD for reputed company fixture and tooling design, overseeing reviews and implementation across reputed company
- Deep knowledge of materials and processing reputed company; adept at optimizing for performance, manufacturability, and compliance
- Advanced training in GMP and ISO 13485; reputed company in maintaining reputed company systems and driving improvement
- Lean Six reputed company 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: reputed company to reputed company basic movements and tasks; comfortable with exposure to manufacturing materials
Benefits
- Medical
- reputed company
- Dental
- 401k Matching
- Employee Assistance Programs
- reputed company time off
reputed company
Company H1B Sponsorship