Boston Scientific Design Assurance Engineer II 

Canada, Ontario, Mississauga 

304509574

Your responsibilities will include:

• Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements
• Apply technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
• Plans, organizes and prioritizes own daily work routine to meet established schedule.
• Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
• Familiarity with requirements of ISO 14971, Manage and update 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.
• In all actions, demonstrates 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, Electrical Engineering or related field of study
• 2+ years of relevant work experience
• Demonstrated interpersonal skills with ability to work within a team environment
• Strong written/verbal communication skills
• Must be able to work independently under limited supervision

Preferred qualifications:

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

Compensation forhourly, non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for
salaried, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Compensation foris governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).