Design Quality Engineer I / Ingénieur en qualité de la conception

Overview

The Design Assurance Quality Engineer (DQA) will work alongside the R&D team to iterate on existing commercial products and perform new product development activities. The DQA Engineer will provide input into the software development processes and ensure product development lifecycle compliance. You will contribute to process improvements (customer experience, manufacturing and servicing), conduct risk assessments, and support regulatory submissions, ensuring compliance with industry standards. This role involves close collaboration with cross-functional teams to evaluate and validate systems.

Your responsibilities

• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Provide quality and compliance input to project teams for project decisions and deliverables (design change analysis, design inputs, design outputs, test methods, design reviews, design verification and validation, usability testing, software validation, process validation and labeling).
• Review and provide input to software detailed design and architectures.
• Provide quality and compliance input for post-market product sustaining activities, such as design changes, non-conforming events, CAPA, field signals evaluations and field actions.
• Contributes to product risk assessment activities and perform Design FMEA’s activities.
• Support the product’s cybersecurity file as per external standards and internal processes.
• Support security risk assessments for medical devices products in development and commercialized.
• Own post-market cybersecurity deliverables for products commercialized (e.g. vulnerability disclosures and monitoring).
• Assist Regulatory with product submissions.
• Support Non-Device Software tool validation.
• Continuously improve processes and work methodologies (using agile/lean principles to eliminate waste) to help solve complex, interdisciplinary problems by interfacing with peers/cross-functional groups.
• Other duties as necessary or required by the organization.

Required qualifications

• Bachelor or Master of Electrical, Biomedical, Computer Science, or equivalent.
• 1+ years of experience with product development activities in a regulated industry.
• Experience in Software Engineering.
• Strong problem-solving skills in a team environment.
• Excellent organizational, communication and collaboration skills.
• Familiar with JIRA.
• Familiar with QMS Systems (Windchill, Master Control etc.).

Compensation and location

Requisition ID : 613360

Minimum Salary : $49,700

Maximum Salary : $98,900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific – 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).

Our organization is across Canada and has commercial representation in 140 countries.

This job involves regular collaboration with colleagues, clients, and stakeholders across Canada, the U.S., and/or internationally, making proficiency in English essential for effective communication and alignment. English is necessary for engaging with a range of documentation and maintaining effective communication if interacting with external clients or vendors.

As detailed in the job description, this job involves communicating, both verbally and in writing, with other Boston Scientific teams located across Canada, the United States and/or with our international clients and partners. International customers and partners represent an important part of our activities. Based on an evaluation, we have determined that the duties of Design Quality Engineer I / Ingénieur en qualité de la conception position require knowledge of English in addition to French (oral and written). We also determined that the English language skills already required of other employees do not permit the performance of English language skills tasks related to Design Quality Engineer I / Ingénieur en qualité de la conception position. However, in Québec, Boston Scientific limits as much as possible the number of positions for which it requires the knowledge of another language than French. Boston Scientific solely requires proficiency in English where it is necessary for the performance of an employee’s duties.

This job involves communicating the organization’s mission and values to colleagues and clients. Our mission is to advance science for life, 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.

So, choosing a career with Boston Scientific isn’t just business, it’s personal. 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!

Job Segment : Biomedical Engineering, Test Engineer, Testing, Quality Engineer, Manufacturing Engineer, Engineering, Technology

J-18808-Ljbffr