Manufacturing Engineering Manager

Eitan Medical is a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home.

The Engineering Manager leads the Manufacturing Engineering Team responsible for optimizing, improving, and supporting the manufacturing processes for our infusion pumps and related products. The ideal candidate will have a strong background in technical process optimization, a deep understanding of single-piece flow production, understanding with single-use devices, and the ability to manage complex engineering activities.

Job Description:

Lead and manage the Engineering team to continuously support and improve production processes.

Optimize single-piece flow production to maximize efficiency, quality, and safety.

Analyse and resolve production issues, ensuring consistent and reliable production output.

Collaborate with cross-functional teams, including R&D, manufacturing, quality, and supply chain, to implement process improvements.

Maintain compliance with regulatory requirements (FDA, ISO 13485) within the production process (incl. process validation) and technical documentation.

Lead engineering change (ECO) projects and technical experiments as a part of related controlled processes implementation.

Foster technical investigations and drive for root cause identification as a part of the NCMR process.

Extending process and product engineering efforts to outsourced manufacturing of administration sets (single use sterile products), ensuring alignment with company standards and regulatory requirements.

Direct manager: Director of Mechanical Engineering

Requirements :

• Education: BSc in Mechanical Engineering from a well-known establishment - a must.

· Job skills:

o 8+ years of experience in Manufacturing Engineering, preferably in a medical devices company with active multidisciplinary devices.

o Deep experience with single-piece flow manufacturing, QA processes and technical documentation management. A track record of successful process support and optimization.

o Strong management skills, with experience leading cross-functional teams and complex engineering projects.

o Knowledge of FDA regulations, ISO standards (ISO 13485), and other relevant regulatory requirements.

· Computer Skills:

o Full control of all Microsoft Office applications

o SolidWorks

· Language skills: Fluent English (written and verbal)

· Personality:

o Strong technical and analytical skills, with the ability to quickly diagnose and resolve complex issues. Superior decision-making and problem-solving skills.

o Excellent communication and leadership abilities to influence teams and collaborate effectively across departments

o Entrepreneurial and results driven with a proven ability to deliver strong results and improve processes. Motivate and lead by example.

o Independent, organized, paying attention to the small details.