Senior Design Quality / Qualité de conception senior

Additional Locations: Canada-QC-Montreal

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.

French translation to follow

About the role: 

We have a high-impact opportunity for a Senior Design Quality professional to lead design assurance efforts for a critical medical device in the Electrophysiology space. This role requires a self-driven professional capable of independently managing complex technical challenges and driving to solutions across hardware, software, and system domains. The Senior Design Quality role will influence strategic quality initiatives, mentor junior engineers, and serve as a key resource in cross-functional teams to ensure product safety, regulatory compliance, and design robustness. 

Work mode:

At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Montreal, Canada location and requires being on-site at least three (3) days per week.

Your responsibilities will include: 

• Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development & validation. 
• Independently lead design control activities for the Capital Equipment, including Design & Development planning, risk management, design verification, and validation efforts, with a strong focus on robustness of system design and documentation. 
• Collaborate closely with R&D, regulatory, manufacturing, and clinical teams  to provide expert guidance on design and compliance matters throughout the product lifecycle. 
• Own and maintain comprehensive risk management files (Hazard Analysis, FMEAs), ensuring robust coverage of both hardware, software, and system risks, applying advanced risk mitigation strategies to influence robust design decisions 
• Lead root cause investigations and resolution of test failures, CAPAs, NCEPs, and complaints, driving corrective actions and preventive measures with minimal oversight. 
• Provide mentorship and guidance to junior engineers on design assurance best practices, regulatory requirements, and quality processes. 
• Proactively identify gaps and opportunities for continuous improvement in product development processes, tools, and documentation. 
• Act as a primary point of contact for design assurance during internal and external audits and regulatory inspections. 
• Effectively manage multiple priorities and projects independently, demonstrating strong decision-making skills in ambiguous situations, and ability to influence project team towards quality-centric decisions and behaviors

Required qualifications 

• Bachelor’s degree in Mechanical, Electrical, Software Engineering, Biomedical Engineering, or related technical discipline. 
• 7+ years of experience in Quality Assurance, Design Assurance, Software Quality, or related roles in the medical device industry. 
• Demonstrated expertise in Design Controls, Risk Management (ISO 14971), Quality System Regulations (21 CFR 820), and Quality management systems (ISO 13485).
• Proven ability to independently lead complex product development projects, including software and system quality assurance activities, from inception through completion. 
• Experience developing and maintaining risk documentation such as FMEAs and Hazard Analyses with a hardware, software and system focus. 
• Strong problem-solving skills with experience leading root cause analysis and CAPA investigations. 
• Excellent communication skills, capable of influencing stakeholders at all levels and leading cross-functional initiatives. 
• Ability to thrive in a fast-paced environment and navigate ambiguity with sound judgment. 

Preferred qualifications 

• Experience mentoring or leading junior engineers in design assurance or software/systems engineering activities. 
• Experience with Capital Equipment
• Knowledge of software quality standards (IEC 62304) and software/system development principles. 
• Prior experience working on or supporting cardiac mapping systems or similar complex medical device platforms. 
• Strong project management skills and familiarity with agile development methodologies. 

Requisition ID: 629670

Minimum Salary: $83,300 

Maximum Salary: $132,300 

The anticipated compensation 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.

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 Senior Design Quality / Qualité de conception senior 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 Senior Design Quality / Qualité de conception senior 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.

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!