Production Engineering
& Manufacturing
Precision-engineered, scalable manufacturing you can trust.
We ensure a seamless transition from product development to high-quality, scalable manufacturing through tightly integrated production engineering, supply chain management, and assembly capabilities. At the intersection of innovation and execution, our Production Engineering team develops efficient, GMP- and LEAN-compliant processes, optimized assembly layouts, detailed work instructions, and custom tools and fixtures. Functional testing at every stage — guided by Six Sigma — drives continuous improvement, supported by full regulatory documentation and validation. Highly skilled engineers and cross-trained production specialists ensure exceptional quality, precision, and consistency across all processes. We specialize in highly precise miniaturized production (e.g. optical modules) and the development of highly integrated instruments. Our in-house capabilities include SMD assembly, AOI/AXI inspection, and comprehensive testing and traceability. Product-dedicated assembly cells deliver flexibility and operational excellence — ensuring reliable, high-performance products tailored to customer requirements. Strategic sourcing, agile project purchasing, and strong supplier partnerships ensure a resilient, cost-efficient supply chain. Closely aligned material planning supports on-time-in-full (OTIF) delivery, backed by robust logistics, trade compliance, and global fulfillment.
Production Engineering
- Interface for a successful design transfer from LRE‘s product development or an external source into series production
- Process design according to GMP guidelines and LEAN principles (customized equipment = property of the customer)
- Assembly line layout definition
- Work procedures & work instructions development
- Creation of jigs, tools, and fixtures
- Functional test development (in-process, module, end-of-line tests)
- Design and implementation of software tools
- Process analysis & continuous improvement (Six Sigma)
- Process FMEA
- Process validation & full regulatory documentation
- Manufacturing process changes and improvement implementation
Manufacturing & Assembly
- In-house SMD assembly line
- In-circuit & functional testing, inline AOI, inline AXI
- 100% component tracing
- Custom, highly integrated device assembly
- Modul and end of line testing
- Product-oriented assembly cells with cross-qualified teams
- Operations excellence: LEAN, Six Sigma, rapid problem solving
Supply Chain Management & Order Fulfillment
- Strategic and project purchasing focused on sourcing strategy development, supplier management, cost optimization, and risk mitigation.
- Order fulfillment and material planning through end-to-end process management, inventory optimization, and coordination to ensure timely delivery.
- Trade compliance ensuring adherence to international regulations (e.g. ITAR, EAR, customs regulations), proper documentation (HTS codes, ECCNs), and collaboration with customs and freight partners.
Our manufacturing facilities –
“Made in Germany”.
LRE Medical operates 40,451 sq. ft. of fully equipped manufacturing space in Noerdlingen, Bavaria, Germany. We are FDA-registered and ISO 13485:2016 compliant, supporting the production of regulated IVDR instruments, medical instruments and life sciences products. We also maintain a dedicated 5,380 sq. ft. SMD assembly area for high-speed, flexible PCB production, along with cleanroom environments of various classifications tailored for the assembly of sensitive components, such as optics.
Seamless transfer from
R&D to production.
Our structured quality gates and cross-functional teamwork throughout the entire product lifecycle enable a seamless transition from development to production. By simultaneous product and manufacturing process development, we accelerate your time-to-market by up to one year.
Excellence in SMD technology & PCB production.
Our in-house SMD technology enables high-speed, flexible PCB production with short lead times, full traceability, and rigorous inline quality control (AOI/AXI). With high OEE levels and in-house component procurement, we ensure maximum availability, reduced supply risk, and improved cost efficiency. Our expert team supports the full lifecycle — from design and assembly to testing and integration — providing critical capabilities for product development, root-cause analysis, and rework when needed.
Lean & Six Sigma –
driving operational excellence.
We apply Lean manufacturing and management principles to enhance quality, efficiency, and effectiveness across the entire value chain. All Lean initiatives are strategically planned and implemented through a one- and three-year OPEX roadmap, with cross-functional teams identifying improvement potential in every stage of the supply and value chain. Lean awareness is deeply embedded in our culture through dedicated projects, workshops, and training. Our Six Sigma approach uses statistical process control to drive continuous improvement, particularly for complex devices and processes. With certified Yellow, Green, and Black Belt experts, our Six Sigma projects consistently deliver measurable results — targeting bottom-line savings of €25k to €100k per project.