Director Process Engineering & NPI - Medtech

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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 manage the Process Engineering department, we are looking for a Director Process Engineering & NPI.

The position will be located mainly in the area of Liège but would require to travel in Europe and US (1 week/month).

Your role

• Lead, mentor, and manage a team of process engineers.
• Lead efforts to optimize manufacturing processes to improve efficiency, reduce costs, and enhance overall product quality.
• Oversee the design and development of manufacturing processes.
• Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Assurance, and Regulatory Affairs, to ensure alignment and successful product launches.
• Drive continuous improvement initiatives to enhance efficiency, yield, and quality.
• Manage projects related to process optimization, scale-up, and new product introductions.
• Ensure the projects are completed on time, within budget, and according to specifications.
• Develop project plans, set milestones, and monitor progress.
• Maintain accurate and up-to-date documentation for all manufacturing processes.
• Provide training and development opportunities for the process engineering team to enhance their skills and capabilities.
• Identify opportunities for process optimization and efficiency gains.

Your profile

• Master’s degree in engineering (mechanics, electromechanics, electronics, etc.).
• 8 years of experience in process engineering, including experience in medical device sector (or higly regulatedd sector).
• Strong understanding of regulatory requirements and quality management systems (ISO 13485).
• 2 years of leadership or project management skills.
• Leadership experience with a focus on process optimization and continuous improvement.
• Knowledge of quality standards and regulatory compliance is a plus.
• Excellent communication and interpersonal skills

Our client’s offer

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