Boston Scientific Quality Design Assurance Associate Co-op/New Grad 

Canada, Ontario, Mississauga 

597193139

The Quality Design Assurance Associate will have the opportunity to work with a cross functional and global group of medical device professionals to ensure that all design and development processes comply with regulations, standards, and internal quality requirements. You will gain an understanding of product design and its history of use to guide design decisions. This role requires a keen problem solver with a strong attention to detail. Conclusions from assessments and investigations will guide engineers in their design decisions to have a direct impact patient care.

Your responsibilities will include:

• Risk Management : Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Support the collection and analysis of key quality trending information and data for specific products
• Design Verification and Validation : Get hands-on experience supporting the development and oversight of test methods to demonstrate medical device safety and efficacy
• Regulatory Compliance and Documentation: Maintain comprehensive and accurate documentation of design processes, changes, and decisions in accordance with regulatory standards (ISO 13485, etc.)
• Continuous Improvement: Help the Design Assurance team achieve their targets for continuous improvement projects to create more efficient and successful processes
• Other duties as required.

Required qualifications:

• Currently enrolled in or recently graduated from a degree program in Engineering or Science
• Ability to extract data from a variety of sources with an understanding of clinical context
• Strong problem-solving skills and attention to detail
• Able to balance multiple priorities at once and work on cross-functional projects
• Proficiency in Excel, including Pivot Tables, to organize, analyze, and present data.

Preferred qualifications:

• Experience with DHF (Design History File) and DMR (Device Master Record) documentation for medical devices.

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).