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

Visa type confirmed: Immigration Support Possible

Job Description

Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – High Performance

At our client, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information, and training, we’ll help you advance your skills and career. Here, you’ll be supported in progressing – 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 subsequent production and process controls for the project are adequate. This is an intermediate-level Engineering position.

Your Responsibilities Will Include:

• Collaborating within 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 in identifying, prioritizing, communicating, and resolving quality issues.
• Building quality into all aspects of work by maintaining compliance to all quality requirements.
• Planning, organizing, and prioritizing own 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 requirements of ISO 14971, managing and updating product risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, 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 to the Quality Policy and all other documented quality processes and procedures.
• Other duties as required.

Required Qualifications:

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

Preferred Qualifications:

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

As a leader in medical science for more than 40 years, our client is committed to solving the challenges that matter most – united by a deep caring for human life. Their mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for customers, and support employees and the communities in which they operate. We encourage you to apply and look forward to connecting with you!

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