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  • Process Engineer Herstal
  • Nyxoah in Herstal, , Belgium
  • jobs
  • 1 week ago

jobs description

Nyxoah is recruiting for a (Mechanical) Process Engineer

What do we do?

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy... Nyxoah started its U.S. pivotal trial in 2021 and recently published the study’s one-year data on the 115 DREAM TRIAL patients: At 12 months, 73 subjects were determined to be AHI responders, per the Sher criteria, resulting in an ITT AHI responder rate of 63.5% (p=0.002), and 82 subjects were determined to be ODI responders, resulting in an ODI responder rate of 71.3%

For more information, please visit http://www.nyxoah.com/.

Location: Milmort, Belgium

Full time.

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 and improvement 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.

Your role
• Develop efficient and effective manufacturing processes / test systems to be implemented in a cleanroom environment.
• Provide process engineering support for manufacturing activities and process improvement projects.
• 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.
• Train operators for the use of equipment and processes.
• Perform / review PFMEA analysis and update.
• Position includes frequent travels abroad.

Your responsibilities
• Conduct exploratory testing / process parameter settings.
• Perform process qualification activities : set out protocols, follow-up on process qualification testing, compile reports.
• Lead different engineering activities with both internal operation team and external manufacturers / suppliers and partners.
• Support R&D with process engineering knowledge (e.g. design for manufacturing).
• Contribute to design concepts from DFMA point of view (requirements, design solutions, prototypes, good manufacturability).
• Highly involved in various technological transfers.
• Analyse and recommend improvements to all production process and methods to facilitate capacity, cost reduction and quality improvement.
• Investigate manufacturing problems for equipment or process related issues.
• Create / update product drawings, manufacturing documents, BOM, etc..
• Proactively identifies issues, troubleshoots, and escalates concerns as appropriate.
• Promote projects with external manufacturers.
• 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.
• Identify proactively issues, troubleshoot issues, and escalate concerns as appropriate.
• Communicate with external manufacturers.

Professional skills Requirements:
• Bachelor’s or master’s degree in engineering or related field
• Preferably 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.
• 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.
• Lean manufacturing and EHS background is a plus.
• Hands on technical experience is an advantage.

Personal skills required
• Enthusiastic and excited to help to build a successful medical device company.
• Proactive, good communicator and innovative.
• Ability to work independently while within a group framework.
• Flexible (as the position requires to travel abroad).
• Excellent proficiency in English (verbal and written).
• Effective communication skills.
• Self-motivated, self-maintained and able to take the initiative to solve problems
• Committed to follow company policies and procedures, follow cGMP and other regulatory requirements.

We thank all applicants for their interest in our organization, however; only those selected for an interview will be contacted
Herstal Belgium

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