Design Assurance Engineer II – Mississauga, Canada – Immigration Support Possible

VISA TYPE CONFIRMED: IMMIGRATION SUPPORT POSSIBLE

Job Opportunity

Our client offers a chance to harness your potential by working with diverse and high-performing teams, tackling some of the most significant health industry challenges. With access to the latest tools, information, and training, you will be supported in advancing your skills and career—whatever your ambitions.

About the Role

Our team is growing, and we are currently looking for a Design Assurance Engineer II to join our Design Assurance Quality team. This position works closely with new product introduction teams to ensure adequate design controls are met and that subsequent production and process controls for the project are effective. This is an intermediate-level Engineering position.

Your Responsibilities Will Include:

• Collaborating with a team to identify and implement effective controls to support the development or maintenance of products to meet internal and external requirements.
• Applying technical skills, including sound, systematic problem-solving methodologies, to identify, prioritize, communicate, and resolve quality issues.
• Building quality into all aspects of work by maintaining compliance with all quality requirements.
• Planning, organizing, and prioritizing your daily work routine to meet established schedules.
• Utilizing standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
• Familiarity with the requirements of ISO 14971, managing and updating product risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, and Design FMEAs.
• Familiarity with IEC 62366 and the application of usability to medical device design.
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
• Other duties as required.

Required Qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical, Electrical Engineering, or a related field of study.
• 2+ years of relevant work experience.
• Demonstrated interpersonal skills with the ability to work well in a team environment.
• Strong written and verbal communication skills.
• Must be able to work independently under limited supervision.

Preferred Qualifications:

• Experience in the medical device industry.
• Familiarity with Ultrasound Imaging and IEC 60601 Standards.
• Training experience in FDA regulations or ISO standards.

Join us to make a meaningful difference to people worldwide! We look forward to connecting with you!

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VJCEngineering