Systems Designer
Zimmer Biomet2 months ago
Montréal, CanadaMid Level
Responsibilities
- Analyze customer and business needs and define functional and technical software system specifications.
- Prepare design and product-development quality documentation and ensure compliance with applicable standards and procedures.
- Plan, coordinate, and support software verification and validation, including test documentation and execution.
- Collaborate with teams to validate new technologies and support innovation.
- Participate in system implementation, user training, and customer support.
- Maintain existing products through preventive and corrective actions.
Requirements
- Experience in software development or software design in an Agile environment.
- Experience as a software verification and validation specialist in an Agile environment.
- Experience with Scrum and Scaled Agile frameworks; Scrum Master certification and experience are an asset.
- Knowledge of 21 CFR Part 11 and 21 CFR 820 regulations.
- University degree in engineering, such as computer science, software engineering, or biomedical engineering, or equivalent.
- At least 3 years of experience in product development as a business analyst or in validation, ideally involving software systems or a highly regulated field.
- Bilingual French and English communication skills, both oral and written.
- Strong analytical, communication, interpersonal, prioritization, collaboration, and problem-solving skills, with an interest in the medical field.
Benefits
- Flexible work environment.
- Competitive location-specific rewards and benefits.
- Employee resource groups.
- Wellness incentives.
- Recognition and performance-reward culture.
- Stimulating and collaborative multidisciplinary work environment.