Engineering Design Release Coordinator

Vital Bio • Oakville, ON

4d • CA$80,000 - CA$95,000 • Onsite

About The Position

The Engineering Design Release Coordinator is responsible for managing and executing Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs). This role involves collaborating effectively within engineering and cross-functional teams to pull together design packages including drawings, specifications, and Bill of Material (BOM). The coordinator will liaise between all stakeholders for the ECO to ensure all documentation is reviewed in a timely manner, and that implementation plans are executed and document repositories are kept up-to-date. Additionally, the role requires working with suppliers to understand requirements, answer technical questions, drive design changes for supplier modifications, and drive verification of transferred items and First Article Inspections (FAIRs). The position also involves partnering with Modality engineers to understand the scope and impact of transfers.

Requirements

• Background in Electrical or Mechanical Engineering (mix of Mechanical & Electrical Engineers ideal).
• Solid understanding of Medical Device Quality Management System (QMS) processes, with hands-on experience.
• Proven experience managing end-to-end design change projects.
• Electrical Engineering background, preferably with medical device knowledge.
• Design Change experience (Inputs, Requirements, Verification, Transfer).
• Ability to read and interpret engineering specifications, drawings, and BOMs.

Nice To Haves

• Experience driving ECR/ECO workflows in a regulated environment.
• Familiarity with supplier qualification, FAIRs, and design transfer activities.
• Experience supporting cross-functional product development or operations teams.
• Comfort working in a fast-paced environment where priorities can shift quickly.
• An appreciation for puns and a collaborative team culture.

Responsibilities

• Manage and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
• Collaborate effectively within engineering and cross-functional teams.
• Pull together design packages including drawings, specifications, and Bill of Material (BOM).
• Liaise between all stakeholders for the ECO to ensure all documentation is reviewed in a timely manner.
• Ensure implementation plans for the ECO are executed and the repositories of documents are kept up-to-date with the latest released information.
• Work with suppliers to understand requirements and answer technical questions.
• Drive design changes (ECOs) to add alternate supplier or change the approved supplier.
• Drive verification of transferred items and First Article Inspections (FAIRs).
• Partner with Modality engineers to understand scope and impact of the transfer.

Benefits

• Compensation will be determined based on the individual’s demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level