Process, Methods and Industrialization Engineer

il y a 15 heures

Pessac, France Fineheart Temps plein

FineHeart S.A. is an innovative start-up in the cardiac field, located in Pessac, in the Bordeaux metropolis. It mainly develops the ICOMS (Intra Cardiac Output Management System), an innovative intracardiac pump, allowing patients suffering from severe heart failure to gain life expectancy and to regain a comfortable life.

Founded by doctors and engineers, it is a technology combining mechanics, electronics and computer science at the service of the clinic in order to offer a completely new alternative to classic cardiac assistance by a more physiological approach and therefore more adapted to the patient.

To support our development, we are looking for a Process, Methods and Industrialization Engineer (M/F).

You will be fully integrated in the Industrialization and Production department and will participate in the development and fine-tuning of class III active implantable medical devices.

You will work under the direct supervision of the Industrialization and Production Department Manager.

By joining us, you will be entrusted with the following missions:

- Development, improvement, analysis, validation of manufacturing processes including but not limited to machining, polishing, assembly, cleaning, packaging and sterilization.

This includes internal manufacturing processes as well as support to Supply Chain teams for external or outsourced activities.

Development, improvement, analysis, validation of adequate control methods for each process.
- Prepare and perform process risk analysis.
- Prepare qualifications and monitoring of infrastructure (equipment and facilities) IQ, OQ, PQ.

Prepare and perform process validation and/or define test level for non-validated processes.

Support for the development and execution of the Design Transfer Plan
- Support for the development and writing of the DMR.
- Support for the elaboration of specifications / requirements.
- Support for engineering and product development teams

**Skills and profiles sought**:
Coming from a general engineering / industrial engineering school or BAC+5 training, you have a minimum of 5 years experience in an Industrialization / Method department.

You master various manufacturing and assembly techniques in the field of mechanics, micromechanics or mechatronics.

You master the qualification of equipment and infrastructures, as well as the validation of manufacturing processes.

You have knowledge of production organizations in a demanding industrial environment, preferably related to Medical Devices.
- Method 6 sigma and Lean would be a plus.
- You are familiar with good manufacturing practices, especially in a clean room environment.
- You are comfortable writing documents in English.

You are rigorous and diligent you are a team player and have a sense of priorities.

You are a team player and have a sense of priorities.
- You are a self-starter and autonomous in the management of your activity.

**Type of job**: Full time, permanent contract.

**Salary** : 40 000,00€ to 60 000,00€ per year.

**Benefits**:

- Salary savings
- Flexible working hours
- Participation in transportation
RTT
- Meal vouchers
- Work from home

**Scheduling**:

- Monday to Friday.
- Rest on weekends.
- Work during the day.

**Types of bonuses and gratuities**:

- Bonuses

**Education**:

- Bachelor’s degree (Master’s / MBA) (required).

**Location of the position**: One place of work.

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