Manufacturing Engineer
iSTAR Medical SA, founded in 2011 and headquartered in Wavre, Belgium, is a medical technology
company focused on the development of MINIject®. MINIject®is a minimally invasive glaucoma
surgery (MIGS) device for patients with glaucoma. Glaucoma is the second leading cause of adult
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blindness globally and the leading cause of irreversible blindness. Our mission is to become the
world leader in minimally invasive implants for glaucoma surgery.
Reporting to the Head of Operations, the Manufacturing Engineer has overall responsibility for
selection, installation and qualification of production equipment. The Manufacturing Engineer is in
charge of developing production processes complying with the company quality and regulatory
standards and cost objectives. The Manufacturing Engineer also acts as the project manager for the
transfer of manufacturing activities to external manufacturers.
Responsibilities
- Design, develop, implement, and improve and validate production cells and manufacturing
processes to ensure consistent quality and optimized efficiency
- Design and develop semi-automated or automated production lines to support long term growth
- Manage transfer of technology to 3rd party manufacturers
- Coordinate production activities
- Lead infrastructure, maintenance and calibration processes
- Represent Manufacturing in Product Development projects
- Ensure effective implementation of risk management in manufacturing
- Support Technical File preparation and maintenance for manufacturing related aspects
- Participate in “health and safety” activities
- Process validation
Profile
• Master's degree in mechanical engineering, process engineering or automation (or equivalent
experience)
- 5 to 10 years of demonstrated experience as manufacturing engineer in the medical device or
- Accustomed to designing / optimizing semi-automated production cells and/or automated
- Good understanding of lean principles
- Experience in managing projects involving 3rd Party manufacturing or technology transfers
- Strong understanding and routine experience of using risk management techniques and root
cause analysis
- Ability to act as a project leader with a high level of commitment
- Experience in Equipment software development (PLC programming), CAD drawing and/or lean Si-
Sigma manufacturing is a plus
- Communicate effectively to all levels of the organization, suppliers and 3rd party manufacturers
- Quality oriented with attention to details
- Fluent in French and English, written and spoken. Knowledge of another language is beneficial.
- Team-player with problem-solving attitude and hands-on mentality, autonomous and self-
environment (hands-on)
- Flexible to travel: < 20%
Offer
The position is based in Belgium (Wavre) with the possibility to work from home a few days a week
and has an international scope.
Headed by a solid management team, you will be part of a highly skilled (engineers, scientists) capable
and dynamic team of innovative leaders with proven track records in the pharmaceutical and medical
device industries.
We have an agile start-up company culture focused on values of entrepreneurship, engagement,
integrity, passion and excellence.
Apply
Please send your CV and a motivation letter to careers@istar-medical.com with reference
Manufacturing_Engineer_2023