Industrialization Engineer, Instruments

Distalmotion SA; Épalinges; In loco; CHF 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

Distalmotion SA in Switzerland seeks an Industrialization Engineer, Instruments, to bring surgical instruments from design to production. You will define manufacturing strategy, develop lines, and transfer designs to contract manufacturers to ensure reliable builds, meeting quality, yield and performance targets as volumes grow.

You will collaborate with R&D, Quality, Production and suppliers to ramp up and continuously improve manufacturing lines, reduce COGS, and ensure compliance with

Competenze

• Engineering degree in microtechnology, mechanical, industrial, or equivalent.
• Minimum 5 years in industrialization or manufacturing engineering for 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 processes (injection molding, ultrasonic welding, machining, assembly, cleaning, sterile packaging) and equipment development and qualification.
• Experience in a controlled environment (cleanroom) is a plus for medical devices.
• Strong data skills (Excel, Power BI, SPC) and knowledge of cost of goods sold (COGS).
• CAD experience (SOLIDWORKS).
• ISO 13485/14971, EU MDR and FDA 21 CFR 820 knowledge a plus; ERP familiarity.
• Analytical, problem-solving mindset with leadership and ownership.
• Fluent in English and French.

Mansioni

• Lead industrialization, design transfer and ramp-up for new products or features related to surgical instruments and components in partnership with R&D, Quality, CMOs and suppliers.
• Analyse instrument costs, review processes and components, identify and implement cost reduction opportunities.
• Drive continuous improvement of manufacturing processes using data-driven problem solving to improve yield, quality, cost and efficiency.
• Lead manufacturing process development, validation or verification and equipment qualification activities.
• Contribute to test strategy improvements and definition of online and end-of-line testing from requirements to design and qualification.
• Initiate and lead Manufacturing Change Requests with R&D, Quality, CMOs; update DMR and FMEA and ensure compliance with standards and Distalmotion QMS.
• Be the voice of manufacturing during product development to ensure manufacturability and efficiency.

Conoscenze

Cross-functional leadership

Lean Manufacturing

Six Sigma

CAPA

8D

Data analysis

English and French

Formazione

Engineering degree (microtechnology, mechanical, industrial or equivalent)

Strumenti

SOLIDWORKS

Excel

Power BI

SPC

Descrizione del lavoro

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.

Duties & 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 (FMEA) and ensure compliance with relevant standards, regulations and Distalmotion'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.

What we offer

• A dynamic, innovative environment with cutting-edge medical technology that is shaping the future of robotic surgery.
• Fast-growing Company where innovation meets agility.
• Structured onboarding program and training, ensuring a confident start.
• High degree of autonomy and flexibility.