Boston Scientific Design Assurance Engineer II 

Canada, Ontario, Mississauga 

313013443

Your responsibilities will include:

• Collaborating within a team to identify and implement effective controls to support 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 with all quality requirements.
• Planning, organizing and prioritizing own daily work routine to meet established schedule.
• Utilizing standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
• Managing and updating product risk management files, specifically Risk Management Plans, Reports, Hazard Analyses, Task Analyses, Design FMEAs in accordance with ISO 14971.
• Supporting design changes for products that have already been commercialized.
• Reviewing design verification and validation protocols and reports.
• Developing test methods and performing test method validations.
• In all actions, demonstrate 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, i.e. reviewing and updating Device Master Records (DMRs), reviewing Device History Files (DHFs), and adhering to a Quality Management System (QMS)
• 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).