Business Analyst

Align Technology; Toronto; On-site; CAD 100,000 - 125,000; Full time

Job summary

A leading medical device company seeks a mid-level Business Analyst to manage software requirements in a regulated environment. The role involves collaborating with clinicians and software engineers, ensuring product quality, and adhering to regulatory standards. Candidates should have a Bachelor's in a relevant field and 5+ years of experience in software requirements, preferably in medical or 3D environments.

Qualifications

• 5+ years working with software requirements, preferably in regulated environments.
• Experience in medical or complex 3D/geometry-based software applications.

Responsibilities

• Gather and document business, clinical, and user requirements.
• Manage traceability across requirements and testing.
• Collaborate with cross-functional teams.

Skills

Strong analytical abilities

Exceptional technical documentation skills

Collaborative mindset

Ability to communicate with stakeholders

Education

Bachelor’s degree in computer science, Engineering, STEM

Tools

Python

SQL

Job description

Position Overview

This position is ideal for a mid-level Business Analyst who will support the Clinical Applications team by defining, documenting, and managing requirements for user-facing software products in a regulated medical device environment. You will collaborate with clinicians, software engineers, and cross-functional stakeholders to translate complex business and clinical goals into clear and testable software requirements. This role is critical to ensuring product quality, regulatory compliance, and successful delivery across research and product development initiatives.

Role expectations

• Gather, analyze, and document business, clinical, and user requirements for 3D and geometry-based software applications.
• Derive detailed use cases and translate high-level product concepts into clear, testable, unambiguous software requirements.
• Collaborate closely with Product Management, Engineering, Software Development, and Quality teams to support development, verification (SQA), and validation activities.
• Manage and maintain traceability across requirements, design, implementation, testing, and release documentation in accordance with regulatory standards.
• Support software releases and change requests by reviewing requirements, participating in impact analysis, and ensuring documentation completeness.
• Contribute to architectural and design discussions, ensuring requirements are aligned with product and technical constraints.
• Interview domain experts to build and maintain a consistent knowledge base and ensure cross-team alignment.
• Work within a formal SDLC and adhere to regulatory and quality documentation practices.

What we're looking for

• Education: Bachelor’s degree in computer science, Engineering, STEM, or equivalent experience.
• Experience: 5+ years working with software requirements, preferably in regulated, medical, or complex 3D / geometry-based software environments.
• Skills: Strong analytical abilities, exceptional technical documentation skills, and a structured approach to requirements and traceability.
• Communication: Ability to communicate clearly with both technical and non-technical stakeholders in cross-functional settings.
• Teamwork: Collaborative mindset with the ability to work independently, take initiative, and support cross-functional delivery.

Complementary skills

• Experience with Agile software development processes.
• Basic understanding of 3D math concepts.
• Experience in Python or SQL.
• Familiarity with medical software, research environments, or R&D workflows.

Pay Transparency

If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically.

For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S.

Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience.