Senior Manufacturing & Process Engineer Medical Device (M/F)
Position: Senior Manufacturing / Process Engineer Medical Device (M/F)
Location: Zürich Switzerland
Start: as soon as possible
Luciole Medical is a leading medical device company located in Zürich Switzerland. The company has a proprietary technology in NIRS and has developed a platform of devices to measure cerebral oxygenation and other hematologic parameters. The company obtained CE mark for its invasive brain monitoring system as well as for the non-invasive patch.
The candidate will develop and implement the industrial manufacturing and the process development activity of the current and the future evolution of the neuro-monitoring platform in compliance with the regulatory requirements and supporting the commercial and clinical launch in Europe.
The function includes:
- Identification, validation and selection of manufacturers and suppliers as well as managing the manufacturing processes for the different system components
- Process development in the areas of sensor technology, analogic and digital electronics, firmware and signal processing
- Conception and implementation of manufacturing plan and budget for the two product lines.
- Scale up, testing and process validation
- Logistic and supply
- Interface with QA/QMS
Report to COO
- Master degree/PhD in engineering, biomedical engineering or similar
- Specific qualification in manufacturing management, QA/QM
- Fluent English, German or French would be a plus
Minimum 3 years in similar function is required in medical device industry.
Familiar with QA/QM environment, applicable norms (ISO, CE mark,…) and regulatory constraints.
We are looking for candidates that are passionate about technology and healthcare, solution oriented, autonomous, rigorous with very high performance standards. He/She is able to interact with manufacturers and suppliers and the other functions of the team (R&D, Clinical, Business Development, QA/QM, …).
True doer, the candidate will play a key role in the development of the company.
Candidate is comfortable in multicultural international environment and able to perform in a start-up environment.
The remuneration includes fix salary, performance bonus as well as participation in the company.