Our client is a health-technology company focused on the development and commercialization of innovative solutions and services to treat sleep disordered breathing conditions.
The company is based in Mont-saint-Guibert and Liège with a Production site in the area of Liège (but also in Israël and Australia) that is currently developing a novel neurostimulation technology to treat Obstructive Sleep Apnea (OSA). The mission of the company is to provide their users, with the freedom to enjoy life to its fullest by delivering reliable, durable and harmonious solutions to treat OSA.
You are looking for a professional challenge that allows you to help to build and work in a start-up / scale-up environment in order to participate to the technology transfer andimprovement of medical device manufacturing activities.
You want to bring your expertise in order to improve manufacturing activities in a GMP and / or ISO 13485 environment. You want to endorse polyvalent responsibilities in order to contribute to face a scaling-up phase.
Develop efficient and effective manufacturing processes / test systems to be implemented in a cleanroom environment.
Perform process qualification activities : set out protocols, follow-up on process qualification testing, compile reports.
Contribute to design concepts from DFMA point of view (requirements, design solutions, prototypes, good manufacturability).
Perform testing and validation by developing and executing validation protocols. Analyse and review verification and validation executed protocols and report for accuracy and correctness including internal consistency, compliance with test plans and test results, and compliance with work procedures.
Highly involved in various technological transfers.
Provide process engineering support for manufacturing activities and process improvement projects.
Analyse and recommend improvements to all production process and methods to facilitate capacity, cost reduction and quality improvement.
Conduct exploratory testing / process parameter settings.
Lead different engineering activities with both internal operation team and external manufacturers / suppliers and partners.
Work closely with R&D, process engineering, manufacturing and quality to define and optimize processes.
Responsible to plan, write and execute equipment and process activities, including verification and validation activities.
Perform investigations when required and suggest and promote corrective and preventive actions for higher performance of equipment or process.
Analyse process capabilities (6 sigma).
Train operators for the use of equipment and processes.
Perform / review PFMEA analysis and update.
Position includes frequent travels abroad.
Professional skills Requirements:
Mechanical /Electromechanical / Material Degree or equivalent experience.
At least 3 years of experience in a highly regulated environment (GMP, ISO 13485) medical device industry preferred.
Demonstrated knowledge of operation principles and practices, and procedures.
Experience in small to mid-size projects execution.
A first experience working with international suppliers and partners.
Ability to communicate effectively with a diverse clientele base.
Ability to work cooperatively with co-workers and external partners. .
English & French - high level (verbal and non-verbal).
Hands on technical experience - advantage.
Personal skills required:
Enthusiastic and excited to help to build a successful medical device company.
Committed to follow company policies and procedures, follow cGMP and other regulatory requirements.
Proactive, good communicator and innovative.
Ability to work independently while within a group framework.
Flexible (as the position requires to travel abroad).
Effective communication skills.
Self-motivated, self-maintained and able to take the initiative to solve problems
If you are interested in this challenging opportunity, please address your application (CV and short motivation text, both in English) to our recruitment partner, Plus One: Mrs. Caroline Franki, by email on email@example.com or apply directly on www.plusonesearch.be
Only selected candidates will be contacted.
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