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Specialist 1, Biomedical Innovation
2 months ago
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.
Responsibilities:
- Participate in the design and development of medical devices while following a quality system in accordance with ISO 13485.
- Prepare engineering 3D models and drawings of products and prototypes.
- Produce and maintain design files in a regulatory framework.
- Participate in risk management and audits.
- Develop and manage design verification and validation activities.
- Manage the transfer of products from design to manufacturing.
- Work with Agile MV Technologies Inc (A Resonetics Company) 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 Technologies Inc (A Resonetics Company), such as quality and manufacturing departments to ensure the development of medical devices.
- May obtain specific limited responsibilities in the project.
- Work independently and carry out specific tasks or small-scale projects with minimal follow-up, advice, and supervision.
- To maximize the effectiveness of the position, this job description is subject to change according to a consensus of the two parties (AgileMV Technologies Inc (A Resonetics Company) and the employee).
Qualifications:
- Graduated with a bachelor’s degree in Engineering, Physical Sciences, or an equivalent.
- Minimum of 3 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-focused, and able to work autonomously.
- Advanced level of oral and written French.
- Advanced level of English to interact with customers and suppliers who are mainly international.
- 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.