Industrialization Engineer, Instruments

About the role

As an Industrialization Engineer, Instruments at Distalmotion in Epalinges, 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 also a key objective, working closely with R&D, Quality, Production and suppliers.

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 processes and components, and implement cost reduction opportunities.
• Drive continuous improvement of manufacturing processes through data-driven problem solving and root-cause analysis to improve yield, quality, cost and efficiency.
• Lead manufacturing process development, validation, verification and equipment qualification.
• Improve 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, update technical documentation (DMR) and the risk management file (FMEA), and ensure compliance with standards, regulations and the company 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).
• At least 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 from process or line development to production, coordinating 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) is a plus.
• Fluent in English and French.

Required skills

• Continuous improvement methods (Lean Manufacturing, Six Sigma, CAPA, 8D) and data skills (Excel, Power BI, SPC).
• COGS calculation and ability to write executive summaries on cost reduction and process improvements.
• CAD software such as SOLIDWORKS.
• ISO 13485, ISO 14971, EU MDR, FDA 21 CFR 820 and ERP knowledge is a plus.

What we offer

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