Boston Scientific Senior Design Assurance Engineer 

Canada, Ontario, Mississauga 

408004783

Your responsibilities will include:

• Work within a cross-functional team to identify and implement effective controls and support product development through commercialization.
• Responsible for design control, risk management & Usability of next-generation capital equipment, Ultrasound Imaging devices.
• Uses clinical knowledge to influence how devices they are working on are tested and designed
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects
• Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team
• Promotes and influences compliance to BSC’s quality, business systems & Industry regulations
• Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines).
• Other duties as required.

Required qualifications:

• Bachelor's Degree in Engineering (Electrical Engineering, Systems Engineering, Biomedical)
• 5+ years of relevant work experience
• Knowledge of Ultrasound imaging devices & IEC 60601-2-37
• Knowledge of ISO 13485, ISO 14971, IEC 62366-1
• Experience with design controls, design inputs and outputs, and risk mitigation activities
• Experience with systems and electrical/software design and test experience with IEC 60601-1 and collateral standards
• Excellent analytical and communication skills (written and oral)
• Excellent organization and time management skills
• Interest in biomedical or health-related industry

Preferred qualifications:

• 2+ years of experience in a Design Assurance role
• 5+ years of experience in the medical device industry

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).