OverviewReporting 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 systemin accordance withISO 13485.
- Prepare engineering 3Dmodelsdrawings of products and prototypes.
- Produce andmaintaindesign files in a regulatory framework.
- Participate in risk management andaudit.
- Develop and manage design verification and validation activities.
- Manage the transfer of products from design to manufacturing.
- Work with Agile MV customers toidentifytheir needs and provide a consulting role throughout the life cycle of medical devices.
- Prepare test reports by collecting,analyzingand summarizing information.
- Collaborate with internal departments of Agile MV, such as quality and manufacturing departments to ensure thedevelopment 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 tomaximize the effectiveness of the position, this job description is subject to change according to a consensus of the 2 parties (AgileMVand the employee).
Required Qualifications
Graduated with aBachelor's degree in Engineering, Physical Sciences or an equivalent
- Minimum of4years of experience in a similar position in theindustry.
- Experience in risk management.
- Knowledge of quality and conformity systems.
- Experience in 3Dmodellingwith SolidWorks software.
- Strong analytical skills, solutions focusonan autonomous manner.
- Advanced level of oral and written French.
- Advanced level of English, to interact with customers and suppliers who aremainly international. Tocomply withinternational industry standards.
- A strong teamplayer able to contribute to discussions.
- Detail oriented, quality focused,meticulousand versatile individual.
- Adaptable,hardworkingand able to work under pressure.
