Application Specialist Biomedical jobs

Job Overview
Reporting to the Senior Director, Biomedical Innovation this member of the Biomedical Innovation team is responsible for the product development process from concept to final design review of mechanical components in existing and new Agile MV Technologies Inc (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.
• Train and support technicians during manufacturing-related activities
• Collaborate with internal departments of Agile MV, such as quality and manufacturing departments to ensure the development of medical devices.
• Take responsibility in the team and in the project.
• Supervise the work of a multidisciplinary team, plans the work, establishes performance.
• May carry out projects from A to Z with the support of the manager.
• To maximize the effectiveness of the position, this job description is subject to change according to a consensus of the 2 parties (Agile MV Technologies Inc «A Resonetics Company» and the employee).

Qualifications

- Graduated with a bachelor’s degree in engineering, Physical Sciences or an equivalent

- Minimum of 5 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 in an autonomous manner.

- Advanced level of English and French, spoken and written.

- 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.

- 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.

Job Types: Full-time, Permanent

Work Location: In person