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

  

Company activity:

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.

 

Job description:

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

 

Organization 

Report to COO

 

Qualification

-       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

 

Experience

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.

 

Profile

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.

 

Remuneration

The remuneration includes fix salary, performance bonus as well as participation in the company.