Design Assurance Engineer II

Additional Locations: 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 Design Assurance Engineer II to join our Design Assurance Quality team. This position works closely with new product introduction teams to ensure adequate design controls are met and subsequent production and process controls for the project are adequate. This is an intermediate-level Engineering position.

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

Requisition ID: 608806

Minimum Salary: $57200 

Maximum Salary: $113700 

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!