Industrialization Engineer, Instruments

About the role

As Industrialization Engineer, Instruments, you will bring surgical instruments and accessories from design to production. You define manufacturing strategy, develop processes and/or lines, and transfer the design to contract manufacturers and suppliers so that products can be built reliably and meet quality, yield and performance targets as volumes grow. Reducing the cost of goods sold (COGS) is a key objective, and you will work closely with R&D, Quality, Production and suppliers to support ramp-up and continuous improvement.

Key responsibilities

• Lead industrialization, design transfer and manufacturing ramp-up of new products, features and components, in partnership with R&D, Quality, contract manufacturers and suppliers
• Analyse instrument costs, review manufacturing processes and components, and identify and implement cost reduction opportunities
• Drive continuous improvement of manufacturing processes using data-driven problem-solving and root-cause analysis to improve yield, quality, cost and efficiency
• Lead manufacturing process development, validation or verification and equipment qualification
• Contribute to test strategies and define and implement on-line and end-of-line testing, from requirements to test design and qualification
• Initiate, assess and lead Manufacturing Change Requests in coordination with R&D, Quality, contract manufacturers and suppliers
• Update technical documentation (DMR) and the risk management file (FMEA), and ensure compliance with standards, regulations and the company's QMS
• Act as the voice of manufacturing during product development to ensure reliable and efficient production

Required profile

• Degree in engineering (microtechnology, mechanical, industrial or equivalent)
• Minimum 5 years of experience in industrialization, manufacturing engineering or process development of complex assemblies in a highly regulated industry, ideally medical devices
• Proven ability to lead cross-functional industrialization projects, including coordination of suppliers and CMOs
• Experience in manufacturing processes such as plastic injection molding, ultrasonic welding, machining, assembly, cleaning, sterile packaging and sealing, and equipment development and qualification
• Experience in a controlled environment (e.g. cleanroom), ideally for medical devices, is a plus
• Hands-on experience in complex assembly of small precision components in high volumes, including fixture and workstation design
• Fluent in English and French

Required skills

• Continuous improvement methods (Lean Manufacturing, Six Sigma, CAPA, 8D) and data skills (Excel, Power BI, SPC)
• Knowledge of COGS calculation and ability to summarize cost reduction and process improvements for executives
• CAD software (e.g. SOLIDWORKS)
• Knowledge of ISO 13485, ISO 14971, EU MDR and FDA 21 CFR 820, and of an ERP system, is a plus

What we offer

• A dynamic, innovative environment with cutting-edge medical technology shaping the future of robotic surgery
• A fast-growing company where innovation meets agility
• Structured onboarding program and training
• High degree of autonomy and flexibility