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 will lead the Engineering team responsible for optimizing and improving the manufacturing processes for our infusion pump products. This role will primarily focus on Manufacturing Engineering for the infusion pumps produced inhouse and of the outsourced production of administration sets. 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 projects.
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.
- Monitor and maintain compliance with regulatory requirements (FDA, ISO 13485) within the production process.
- Oversee the introduction of new production processes or modifications to existing processes to enhance efficiency and reduce costs.
- Provide technical expertise and guidance to ensure smooth transitions in engineering changes.
- Foster technical investigations and drive for root cause identification as a part of the NCMR process.
- Lead Engineering experiments as a part of the related controlled processes.
- Extend process and product engineering efforts to outsourced manufacturing of administration sets, ensuring alignment with company standards and regulatory requirements.
- Leading engineering projects and changes, managing both internal and external stakeholders.
- Foster a culture of continuous improvement, identifying opportunities to introduce innovative technologies or methodologies into production.
Direct manager: Director of Mechanical Engineering
Job Requirements:
- Education: Bachelor’s degree in Mechanical Engineering - must.
- Job skills:
o 8+ years of experience in Engineering in Hi-Tech industry, preferably in medical devices company with active devices.
o Experience with single-piece flow manufacturing processes and a track record of successful process optimizations.
o Strong project 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: Proficiency in Office products - Must
· Language skills: Fluent English - High level
· Personality:
o Strong technical and analytical skills, with the ability to quickly diagnose and resolve production issues.
o Excellent communication and leadership abilities to influence teams and collaborate effectively across departments
o Motivate and lead by example
o Entrepreneurial and results driven with a proven ability to deliver strong results and improve processes.
o Independent, organized, paying attention to the small details
o Superior decision-making and problem-solving skills, ability to diagnose problems quickly and have foresight into potential issues
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