Senior Design Assurance Engineer

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.

Our team is growing, and we are currently looking for a Senior Design Assurance Engineer to join our Design Assurance Quality team. This position works closely with Medical Ultrasound Imaging products to ensure adequate design controls. The Design Assurance Engineer will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and will provide design support. 

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 

Requisition ID: 612736

Minimum Salary: $79700 

Maximum Salary: $158200 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

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

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

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!