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  • NPI Process Engineer - Medtech Liège
  • Plus One in Liège, , Belgium
  • jobs
  • 1 month ago

jobs description

About our Client

Our client, Nyxoah ( https://www.nyxoah.com ), is a health-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 CE-mark validated, user-centered, bilateral neurostimulation therapy to treat moderate to severe Obstructive Sleep Apnea (OSA), the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.

In September 2021, the US Food and Drug Administration (FDA) has granted the Genio® bilaterial hypoglossal nerve stimulation system Breakthrough Devise Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate.

The Breakthrough Designation is supported by data from the Company’s BETTER SLEEP trial, aimed at addressing the long-term safety and... performance of the Genio® system in adult OSA patients with and without CCC.

To reinforce their Process Engineering department, located in teh area of Liège, they are looking for a NPI Process Engineer;

Your role

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.

Purpose

· 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.

· Analyse process capabilities (6 sigma).

· Identify proactively issues, troubleshoot issues, and escalate concerns as appropriate.

· Communicate with external manufacturers.

· Perform other duties assigned as needed.

Your profile

Professional skills Requirements:

· Engineering Degree in Mechanics or Electromechanics.

· 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 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 background.

· English - high level (verbal and non-verbal). French is a plus

· Hands on technical experience - advantage.

· Knowledge of Solidworks (or equivalent software) is a plus.

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.

Our client's offer

Beyond a competitive salary and attractive benefits, our client offers you a challenging opportunity in an agile company
Liège Belgium

salary-criteria

Apply - NPI Process Engineer - Medtech Liège