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This industry-leading pharmaceutical company in Downtown Montreal is looking for a System Designer
Job Responsibility
Analyze various needs (user, business, regulatory, etc.) and define system specifications, taking into account technical and functional requirements
Identify, evaluate and analyze product risks
Participate in product verification and validation
Participate in usability testing with customers
Manage requirements traceability
Write quality documents related to product design and development in compliance with applicable standards and procedures to ensure product quality and safety
Participate in training and customer support for our system
Participate in the maintenance of existing products
Work in an Agile and Scrum environment
Interact with different teams to explore new technologies in order to achieve above-standard reliability and product quality, enabling the company to maintain its position as a leader in the industry
Requirements
Ability to effectively manage priorities and deadlines
Ability to work independently and effectively as part of a team
Ability to deal with pressure and ambiguity, build consensus, manage multiple priorities and identify creative solutions to complex problems
Strong analytical and judgmental skills
High level of personal responsibility and integrity
Solid experience in identifying and analyzing product risks
Ease of interaction and collaboration with people from other fields
Excellent adaptability and ability to work in a constantly evolving, state-of-the-art environment
Excellent written and verbal communication skills in French and English
Bachelor's degree in engineering or science in a related field (computer science, software engineering, biomedical or equivalent)
3 to 5 years' experience in R&D product development, ideally in a highly regulated field (medical, aerospace or pharmaceutical)
Nice to have
Product Owner, or Scrum Master
Software verification/validation specialist
Experience with Agile/Scrum development teams and with Confluence and Jira
Knowledge of medical design regulations (e.x. 21 CFR 820, ISO13485, ISO14971, IEC62304, IEC62366, etc)