R&D Systems Engineer II / ingénieur II en systèmes de R et D

Boston Scientific Gruppe; Montreal; On-site; CAD 79,000 - 159,000; Full time

Job summary

A leading medical device company in Montreal is seeking an R&D Systems II Engineer to enhance product development by ensuring high standards of software design and compliance. The successful candidate will collaborate with various teams to translate user needs into robust software requirements, manage traceability, and partake in risk management activities. Ideal candidates will hold a degree in software engineering or a related field, with 2+ years of relevant experience in a regulated environment, and must possess strong problem-solving and communication skills.

Qualifications

• 2+ years of experience in product development within a regulated sector.
• Strong experience authoring and analyzing software requirements.
• Familiarity with troubleshooting software test failures.

Responsibilities

• Translate user needs into software design requirements.
• Manage software requirements and ensure traceability.
• Contribute to software architecture design.

Skills

Software requirements analysis

Problem-solving skills

Organizational skills

Collaboration skills

Software system engineering

Communication skills

Education

Bachelor's degree in software engineering or related field

Job description

Onsite Location(s): Montreal, QC, CA

Additional Location(s): 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.

About the role

As an R&D Systems II, Software, you will be an integral part of our product development process, ensuring that our systems meet the highest standards of performance, reliability, and compliance. You’ll work closely with cross-functional teams to translate user needs into detailed system and software requirements, develop design architectures, and contribute to risk management and validation activities. Your expertise will help us create innovative solutions in a highly regulated environment, directly impacting the success of our products and ultimately improving lives.

Your responsibilities will include:

• Participate in project teams to translate user needs into software design requirements.
• Manage software requirements, ensuring traceability using requirements management tools.
• Contribute to software architecture design and integration strategies across sub-systems (software, firmware, and hardware interfaces).
• Document and architect communication protocols between software components and other sub-systems.
• Support risk management activities, including Hazard Analysis and Design FMEA for software components.
• Perform software-focused engineering studies and write technical reports.
• Provide expertise and conduct evaluation of software verification and validation activities.
• Initiate and document design change assessments for new and sustaining software products.
• Manage & maintain the JIRA backlog, prioritize software features, participate in bug triage and support agile development practices.
• Assist in bridging software sub-system designs and integrating features at a system level.
• Collaborate with cross-functional teams as an R&D representative on software deliverables.
• Continuously improve software development processes using agile/lean principles.
• Maintain strong understanding of medical device software design control processes.

Required Qualifications

• Bachelor's degree in software engineering, computer engineering, or a related field.
• 2+ years of experience in product development within a regulated sector.
• Experience in software systems engineering and verification activities.
• Strong experience authoring and analyzing software requirements.
• Familiarity with troubleshooting software test failures.
• Excellent problem-solving skills in a team environment.
• Strong organizational, communication, and collaboration skills.

Preferred Qualifications

• Experience leading software development teams in a regulated environment.
• Understanding of embedded (real-time) software design trade-offs, performance, and redundancy issues.
• Extensive knowledge of advanced software testing concepts and formal verification strategies for regulated software.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and ISO 14971.
• Ability to interact with and influence key stakeholders internally and externally.

Requisition ID: 619596

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).

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 R&D Systems Engineer II / ingénieur II en systèmes de R et D 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 R&D Systems Engineer II / ingénieur II en systèmes de R et D 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.