As a direct report to the COO, you are responsible for all process engineering and NPI endeavours in a new commercial manufacturing plant and tasked to ensure compliance with medical device regulations and requirements in terms safety and quality

What will you be doing?

• You ensure processes meet technical and functional specifications and standards, and oversee process validation activities and documents. You develop procedures to meet regulatory, safety and quality requirements.
• You set up a manufacturing line that is ready to produce for the European market, working closely with R&D and Quality to ‘design for manufacturing’ for current and future implant generations.
• You collaborate and coordinate with the main contract manufacturer in the USA, as well as with other suppliers spread across Europe. When needed, you also engage with regulatory bodies and other external parties.
• You search for inefficiencies and opportunities to improve the manufacturing line, challenging the status quo and promoting pragmatism across the broader organization.
• You lead a team of 4 process engineers and grow the team in function of knowledge and general skills, supporting in-house experience and expertise around MedTech and process engineering.

Who are we searching for?

• You can rely on previous experience in the medical technology sector and understand the complex dynamics typical for a manufacturing or R&D organization. Working in a highly regulated industry has become a routine.
• You bring good knowledge of LEAN and continuous improvement principles, and have a track record in designing or implementing optimization strategies.
• You bring the right technical knowledge concerning process validation, NPI, process FMEA, process (performance) qualification, etc. Familiarity with ISO 13485, MDR and FDA/CFR regulations is strongly advised.
• You have managed and coached a technical team before, and are able to develop specific guidance and development plans on an individual basis. The success of the team is your personal success.
• You are fluent in English, both in its written and spoken form. Knowledge of French is an asset. Moreover, relocation to or working in Belgium is not an issue for you.

Why should you join us?

• You take an opportunity to contribute to the growth and expansion of an ambitious MedTech company and will play an important role in future success.
• You come in a function that requires you to think strategically but also to be hands-on and operationally involved.
• You receive the clear mandate to grow your department and team, to foster future growth and build alignment between internal departments.
• You can travel frequently across Europe and to the USA, to visit suppliers and other partners.
• You will enjoy all benefits of a Belgian contract and receive a fair but competitive salary package.

Interested?
Please send your CV and cover letter through www.mercuriurval.com (ref.no. BE-07626). Alternatively, or for more additional information, please contact Wouter Snauwaert on wouter.snauwaert@mercuriurval.com.

• You ensure processes meet technical and functional specifications and standards, and oversee process validation activities and documents. You develop procedures to meet regulatory, safety and quality requirements.
• You set up a manufacturing line that is ready to produce for the European market, working closely with R&D and Quality to ‘design for manufacturing’ for current and future implant generations.
• You collaborate and coordinate with the main contract manufacturer in the USA, as well as with other suppliers spread across Europe. When needed, you also engage with regulatory bodies and other external parties.
• You search for inefficiencies and opportunities to improve the manufacturing line, challenging the status quo and promoting pragmatism across the broader organization.
• You lead a team of 4 process engineers and grow the team in function of knowledge and general skills, supporting in-house experience and expertise around MedTech and process engineering