Senior System Engineer

Penta Search Group; Burnaby; On-site; CAD 80,000 - 120,000; Full time

Job summary

An established industry player is searching for a Senior Systems Engineer to join their R&D team in Burnaby. This pivotal role involves driving the technical definition and system architecture of innovative medical devices. You will lead requirements development, ensure compliance with regulatory standards, and facilitate risk assessments to mitigate system-level risks. The ideal candidate will have extensive experience in technical product development, particularly within regulated industries, and a strong background in system design and project management. If you are passionate about advancing patient care through cutting-edge technology, this opportunity is perfect for you.

Qualifications

• 8+ years of experience in technical product development in regulated industries.
• Expertise in system design, testing, risk analysis, and technical documentation.

Responsibilities

• Lead requirements development and verification processes for medical devices.
• Collaborate with cross-functional teams to translate user needs into specifications.

Skills

System Design

Risk Analysis

Technical Documentation

Project Management

Independent Decision-Making

Education

Bachelor's degree in Engineering

Master's degree or professional certification

Tools

Systems Engineering standards (e.g., INCOSE)

Job description

Direct message the job poster from Penta Search Group

Recruitment & Executive Search | Procurement | Supply Chain | Manufacturing | Chemicals

Burnaby, BC

Company Overview

Our client is a leading global medical device company dedicated to advancing patient care through innovative, high-quality products. Recognized for pioneering solutions in critical healthcare areas such as bladder volume measurement and airway management, the organization prioritizes clinical excellence, regulatory compliance, and continuous improvement. As part of a larger multinational corporation, the company operates across North America, Europe, and Asia Pacific, with a commitment to elevating standards of care worldwide.

Overview

We are seeking a Senior Systems Engineer to join our client’s R&D team in Burnaby, British Columbia. This role is pivotal in driving the technical definition and system architecture of cutting-edge medical devices, ensuring alignment with user needs and regulatory requirements.

Responsibilities

• Lead requirements development and verification processes, ensuring compliance with FDA and other regulatory standards.
• Develop systems architecture documentation to define subsystems, interfaces, and integration strategies.
• Facilitate risk assessments, including FMEA, to mitigate system-level risks.
• Manage product requirements traceability using industry-standard tools.
• Collaborate with cross-functional teams (clinical, marketing, engineering) to translate user needs into technical specifications.
• Serve as the primary technical liaison across stakeholder groups during product development.
• Support validation/verification strategies and analyze design changes for existing products.
• Deliver project timelines, ensuring on-time completion of systems engineering deliverables.
• Mentor junior engineers and contribute to process improvements within Systems Engineering.

Qualifications

• Bachelor’s degree in Engineering or Applied Physics (Master’s or professional certification preferred).
• 8+ years of experience in technical product development, preferably within regulated industries.
• Expertise in system design, testing, risk analysis, and technical documentation.
• Proficiency with Systems Engineering standards (e.g., INCOSE) and tools.
• Familiarity with medical device standards (ISO 13485, ISO 14971) is highly desirable.
• Strong project management skills with the ability to prioritize in fast-paced environments.
• Independent decision-making grounded in engineering principles and sound judgment.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Medical Equipment Manufacturing