Industrialization Engineer, Instruments (m/w/x)
Developing manufacturing processes for surgical instruments and accessories. 5+ years in industrialization for complex medical devices required. Autonomy and flexibility in a cleanroom environment.
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Anforderungen
- Degree in engineering (microtechnology, mechanical, industrial, or equivalent)
- Minimum 5 years 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
- 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 manufacturing site operating in controlled environment (e.g. cleanroom), ideally for medical devices
- Hands-on experience in complex assembly of small precision components in high volumes, including fixture and workstation design
- Knowledge of continuous improvement methods (Lean Manufacturing, Six Sigma, CAPA, 8D)
- Strong data skills (Excel, Power BI, SPC)
- Knowledge of COGS calculation
- 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
- Knowledge of an ERP system
- Analytical, solution-oriented mindset
- Strong sense of leadership and ownership
- Fluent in English
- Fluent in French
Aufgaben
- Define manufacturing strategy for instruments and accessories
- Develop manufacturing processes and/or lines
- Transfer designs to contract manufacturers and suppliers
- Ensure reliable product builds meeting quality, yield, and performance targets
- Reduce the cost of goods sold (COGS) for instruments
- Support ramp-up and continuous improvement of instrument manufacturing lines
- Lead industrialization, design transfer, and manufacturing ramp-up for new products
- Analyze instrument costs and manufacturing processes
- Identify, evaluate, and implement cost reduction opportunities
- Drive continuous improvement of manufacturing processes using data-driven problem-solving
- Improve yield, quality, cost, and efficiency through root-cause analysis
- Lead manufacturing process development, validation, and verification
- Lead equipment qualification activities
- Contribute to improving test strategies
- Define and implement on-line and end-of-line testing
- Initiate, assess, and lead Manufacturing Change Requests
- Update technical documentation (DMR) and risk management files (FMEA)
- Ensure compliance with relevant standards, regulations, and QMS
- Represent manufacturing during product development to ensure manufacturability
Berufserfahrung
Ausbildung
Sprachen
Tools & Technologien
Benefits
- Structured onboarding and training
- Autonomy and flexibility
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Distalmotion SA erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Distalmotion SAÜber das Unternehmen
Distalmotion is a global MedTech company simplifying robotic surgery with its DEXTER® robot to empower access to minimally invasive care.
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