Quality Engineer I, Design Assurance

Boston Scientific Gruppe; Mississauga; On-site; CAD 49,000 - 99,000; Full time

Job summary

A leading medical device company is seeking a Quality Engineer I to join their growing team in Mississauga, Peel Region, Canada. The role involves working closely with New Product Development teams to ensure adequate design controls and production compliance. Candidates should have a Bachelor's degree in Biomedical or Engineering fields and relevant experience in the Medical Device Industry. The position emphasizes teamwork, problem-solving, and quality enhancement across projects.

Qualifications

• 1+ year of related work experience from Medical Device Industry.
• Ability to travel (less than 25%).

Responsibilities

• Identify and implement effective controls for product development.
• Develop understanding of Design Controls, Risk Management, and Usability.
• Apply repeatable problem-solving concepts.

Skills

Interpersonal skills

Problem-solving

Education

Bachelor’s degree in Biomedical Engineering, Mechanical, Electrical Engineering or related field

Job description

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Additional Locations: Canada-ON-Mississauga; Canada-ON-Toronto

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

At Boston Scientific, 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 in advancing 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 Quality Engineer I, Design Assurance to join our Quality team. This position works closely with New Product Development teams to ensure risk management is applied and to ensure adequacy design controls as well as production and process controls. Our team also works to enhance quality as a whole through design quality assurance and compliance improvement projects.

Your responsibilities will include:

• Working within a team to identify and implement effective controls to support development and maintenance of products to meet internal and external requirements
• Developing understanding of Design Controls, Risk Management and Usability for Medical Devices
• Applying repeatable problem-solving concepts
• Keeping abreast of standard practices
• Supporting departmental, functional, and divisional design quality goals and priorities.
• Building quality into all aspects of work by maintaining compliance to all quality requirements
• Participating in various design quality assurance and compliance improvement projects
• Other duties as necessary or required by the organization

Required qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical, Electrical Engineering or related field of study
• 1+ year of related work experience from Medical Device Industry
• Demonstrated interpersonal skills with ability to work within a team environment
• Ability to travel (less than 25%)

Preferred qualifications:

• Six Sigma problem solving methodologies
• Knowledge of ISO 13485, ISO 14971, IEC 60601
• Medical imaging experience

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Requisition ID: 623019

Minimum Salary: $49700

Maximum Salary: $98900

Compensation will vary based on location and other relevant factors.

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Medical Device, Biomedical Engineering, QA, Quality Assurance, Quality Engineer, Healthcare, Engineering, Quality, Technology