Industrialization Engineer
A medical robotics company is seeking an Industrialization Engineer to lead the transition of surgical instruments and accessories from design to high-volume production. The role focuses on defining manufacturing strategies, developing production lines, and managing design transfers to contract manufacturers and suppliers. The successful candidate will ensure products meet quality, yield, and performance targets while actively driving cost reduction (COGS) initiatives. This position involves close collaboration with R&D and Quality teams to support manufacturing ramp-up and continuous improvement in a highly regulated environment.
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Opportunity overview
Required role
Required platforms
Required skills
Required industry experience
Responsibilities
- Lead industrialization, design transfer, and manufacturing ramp-up for new surgical instruments and components.
- Analyze instrument costs and identify manufacturing process improvements to achieve cost reduction targets.
- Drive continuous improvement using data-driven problem-solving and root-cause analysis to enhance yield and efficiency.
- Lead manufacturing process development, validation, verification, and equipment qualification activities.
- Contribute to test strategies and the implementation of on-line and end-of-line testing protocols.
- Initiate and lead Manufacturing Change Requests (MCR) in coordination with cross-functional teams.
- Update technical documentation (DMR) and risk management files (FMEA) to ensure regulatory compliance.
- Act as the voice of manufacturing during product development to ensure Design for Manufacturing (DFM) principles.
Requirements
- Degree in engineering (microtechnology, mechanical, industrial, or equivalent).
- Minimum 5 years of experience in industrialization or process development for complex assemblies.
- Proven ability to lead cross-functional projects from process development to production with CMO coordination.
- Experience with manufacturing processes such as injection molding, ultrasonic welding, machining, and sterile packaging.
- Hands-on experience in complex assembly of small precision components and workstation design.
- Knowledge of continuous improvement methods including Lean Manufacturing, Six Sigma, CAPA, and 8D.
- Proficiency in CAD software such as SOLIDWORKS and data tools like Excel or Power BI.
- Familiarity with medical device standards including ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR 820.