Job Description

Reporting to the Sr. Director Agile Engineering, this member of the product development team is responsible for the product development process from concept to final design review of mechanical components in existing and new AgileMV (a Resonetics company)products. Ensuring the smooth running of all operations activities in line with ISO 13485, FDA, GMPs, CE mark such as the following tasks;

Responsibilities

• Participate in the design and development of medical devices while following a quality system in accordance with ISO 13485.

• Prepare engineering 3D models drawings of products and prototypes.

• Produce and maintain design files in a regulatory framework.

• Participate in risk management and audit.

• Develop and manage design verification and validation activities.

• Manage the transfer of products from design to manufacturing.

• Work with Agile MV customers to identify their needs and provide a consulting role throughout the life cycle of medical devices.

• Prepare test reports by collecting, analyzing and summarizing information.

• Collaborate with internal departments of Agile MV, such as quality and manufacturing departments to ensure the development of medical devices.

• Train and support operators and Technicians during manufacturing-related activities

• Take responsibility in the team and in the project.

• Can lead complex projects through all phases with minimal advice.

• Supervise the work of a multidisciplinary team, plan the work, established performance.

• In order to maximize the effectiveness of the position, this job description is subject to change according to a consensus of the 2 parties ( AgileMV and the employee).

Required Qualifications

Graduated with a Bachelor's degree in Engineering, Physical Sciences or an equivalent

• Minimum of 4 years of experience in a similar position in the industry.

• Experience in risk management.

• Knowledge of quality and conformity systems.

• Experience in 3D modelling with SolidWorks software.

• Strong analytical skills, solutions focus on an autonomous manner.

• Advanced level of oral and written French.

• Advanced level of English, to interact with customers and suppliers who are mainly international. To comply with international industry standards.

• A strong team player able to contribute to discussions.

• Detail oriented, quality focused, meticulous and versatile individual.

• Adaptable, hardworking and able to work under pressure.