Technical Lead, NPI Manufacturing Engineer
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Skills
About the role
Who We Are
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
About You
- Provide leadership and guidance to the Manufacturing Engineering team (ME) during NPI New Product Introduction through sustaining.
- Manages ME processes, improvements, and execution of time based deliverables
- Implement lean manufacturing principles, drive continuous improvement initiatives, and utilize data analytics to streamline ME operations, increase productivity, and reduce cost in processes.
- Creates and improves processes and procedures for ME and related areas.
- Excellent theoretical, analytical, and practical skills; appropriately applied to resolving manufacturing issues.
- Develops and supports effective product field returns strategy and procedures
- Escalates and resolves design, manufacturability, quality, and supply chain issues
- Responsible for setting up DMR/DHR/LHR management for a complex system
- Creates workflow process diagrams, detailed manufacturing and shipping work instructions, procedures, checklists, travelers, product and equipment maintenance plans
- Develops floor and line layout proposals for build capacity, quality, time optimization and effective inventory management
- Participates in BOM management, technical specification reviews, new part requisitions
- Leads process failure mode and analysis (PFMEA) activities
- Develops and validates critical tests used in production workflow to minimize risk
- Responsible for the activities of validation and qualification of manufacturing equipment and processes utilizing standard qualification approaches (IQ/OQ/PQ)
- Manages development and delivery of completed validation plans, studies, and reports
- Provides feedback for product and process DFM improvements to R&D to ensure optimal manufacturability and serviceability
- Provides technical support in analyzing and/or performing investigation for discrepant production components, assemblies, and field returns
- Assists with assembly, testing, and troubleshooting of new products
- Provides leadership, training, and technical support to production technicians
- Implements fixtures to aid in production, maintenance, and service
- Support Good Manufacturing Practices and quality management system in accordance with FDA regulatory and ISO 13485 requirements.
- Other related duties.
Qualifications
- Minimum a four-year degree (Bachelor’s) in industrial or mechanical engineering or an equivalent combination of education and experience in medical devices with QSR/FDA ISO 13485:2016 or in a highly regulated manufacturing environment
- Need a minimum of 5 years of experience in manufacturing engineering of complex electromechanical devices and medical device
- Must be able to read and understand assembly drawings, BOMs, workflow diagrams, MPIs, and read basic schematics