Design Quality Engineer I / Ingénieur En Qualité De La Conception

Design Quality Engineer I / Ingénieur En Qualité De La Conception

The Design Assurance Quality Engineer (DQA) will work alongside the R&D team to iterate on existing commercial products and perform new product development activities. The DQA Engineer will provide input into the software development processes and ensure product development lifecycle compliance. You will contribute to process improvements (customer experience, manufacturing and servicing), conduct risk assessments, and support regulatory submissions, ensuring compliance with industry standards. This role involves close collaboration with cross-functional teams to evaluate and validate systems.

Your responsibilities will include:

• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Provide quality and compliance input to project teams for project decisions and deliverables (i.e Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design Verification and Validation, Usability Testing, Software Validation, Process Validation and Labeling).
• Provide support in developing Software Development Plans, Unit & Integration Test Plans.
• Review and provide input to Software Detailed Design and Architectures.
• Provide quality and compliance input for post market product sustaining activities, such as design changes, non-conforming events, Corrective and Preventive Actions (CAPA), Field Signals Evaluations and Field Actions.
• Contributes to product risk assessment activities and perform Design FMEA's activities.
• Support the product's cybersecurity file as per external standards and internal processes.
• Support security risk assessments for medical devices products in development and commercialized.
• Own post-market cybersecurity deliverables for products commercialized (i.e. Vulnerability disclosures and monitoring).
• Assists Regulatory with product submissions.
• Support Non-Device Software tool validation.
• Continuously improve processes and work methodologies (using agile/lean principles to eliminate waste) to help solve complex, interdisciplinary problems by interfacing with peers/cross-functional groups.
• Other duties as necessary or required by the organization.

Required qualifications:

• Bachelor or Master of Electrical, Biomedical, Computer Science, or equivalent.
• 1+ years of experience with product development activities in a regulated industry.
• Experience in Software Engineering.
• Strong problem-solving skills in a team environment.
• Excellent organizational, communication and collaboration skills.
• Familiar with JIRA
• Familiar with QMS Systems (Windchill, Master Control etc.)