Role summary
As an Industrialization Engineer, Instruments, you will play a key role in bringing our surgical instruments and accessories from design to production. You will define manufacturing strategy, develop processes and/or lines, and transfer the design to our contract manufacturers and suppliers. You will make sure that products can be built reliably and meets quality, yield and performance targets as volumes grow. Reducing the COGS of our instruments will also be a key objective of your role. You will work closely with R&D, Quality, Production team and suppliers to support the ramp-up and the continuous improvement of our instruments manufacturing lines.
Responsibilities
- Lead the industrialization, design transfer and manufacturing ramp-up of new product or new feature introduction project related to surgical instruments, accessories and their components, in close partnership with R&D, Quality, Contract Manufacturers and Suppliers.
- Analyse the cost of the instrument, review the manufacturing processes and components, identify, evaluate 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 activities.
- Contribute to the improvement of test strategies, and to the definition and implementation of 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 Manufacturer and suppliers. Update the technical documentation (DMR) and the risk management file () and ensure compliance with relevant standards, regulations and the organization's QMS.
- Be the voice of manufacturing during product development to ensure that products can be manufactured reliably and efficiently.
Requirements
- 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 with ownership, from manufacturing process or line development to production, including coordination of suppliers and CMOs.
- Experience in manufacturing process (e.g. plastic injection molding, ultrasonic welding, machining, assembly, cleaning, sterile packaging and sealing) and equipment development and qualification.
- Experience in a manufacturing site operating 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 the design of fixtures and workstations.
- Knowledge of continuous improvement methods (Lean Manufacturing, Six Sigma, CAPA, 8D) and strong data skills (Excel, Power BI, SPC).
- Knowledge of COGS calculation and ability to synthesize executive summaries on cost reduction and process improvements.
- Knowledge of CAD software (e.g. SOLIDWORKS).
- Knowledge of ISO 13485, ISO 14971, EU MDR and FDA 21 CFR 820, and of a ERP system, is a plus.
- Analytical, solution-oriented mindset with a strong sense of leadership and ownership.
- Fluent in English and French.
Standards
- ISO 14971 Medical Devices - Application of Risk Management