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Validation Engineer Biomedical Jobs in Toronto, ON

Conavi

Senior Manufacturing Engineer

Toronto, ON · On-site

Develop and execute IQ/OQ/PQ validations for catheter-based disposable products (e.g. bonding ... Bachelor's or above degree in engineering (Mechanical, Biomedical, Manufacturing, or related field)

Vantive

Digital Service Specialist

Mississauga, ON

Collaborate with biomedical engineering staff at customer sites to support operational continuity ... Valid driver's license required. * Demonstrate interpersonal skills that embrace Vantive's cultural ...

DNAstack

Bioinformatics Analyst

Toronto, ON · Remote

... biomedical data sharing, discovery, and analysis. We build cutting-edge software and industry ... Were a nimble, cross-functional team of scientists, engineers, designers, and product thinkers ...

DNAstack

Bioinformatics Analyst

Toronto, ON

... biomedical data sharing, discovery, and analysis. We build cutting-edge software and industry ... We're a nimble, cross-functional team of scientists, engineers, designers, and product thinkers ...

Gehc

Field Service Apprentice - ON

Mississauga, ON

... Biomedical Engineering Technology, Mechatronics, or a related technical field. * Ability to ... Must hold a valid full Canadian provincial driver's license at the time of application. * Must be ...

Excelitas Technologies

Buyer III

Mississauga, ON · On-site

... biomedical, semiconductor, industrial, consumer products, scientific, security, defense and ... Obtain quotes for production quantities, validate, recommend/choose best option, set up parts in ...

All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in Toronto, ON

Validation Engineer Biomedical information

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are some typical challenges faced by validation engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What are the key skills and qualifications needed to thrive as a validation engineer in biomedical?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What does a validation engineer do in biomedical?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.
What are popular job titles related to Validation Engineer Biomedical jobs in Toronto, ON? For Validation Engineer Biomedical jobs in Toronto, ON, the most frequently searched job titles are:
Validation Engineer Biomedical jobs near you
Infographic showing various Validation Engineer Biomedical job openings in Toronto, ON as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Archive Verification and Validation Engineer

Merative

Mississauga, ON • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 14 days ago

Job description

Merge medical imaging solutions, offered by Merative, combine intelligent, scalable imaging workflow tools with deep and broad expertise to help healthcare organizations improve their confidence in patient outcomes and optimize care delivery.
The Product Quality Assurance (PQA) Engineer is responsible for verification and validation of the Merge Vendor Neutral Archive (VNA) platform and associated imaging workflows. The role provides independent quality oversight throughout the software development lifecycle and ensures that released software meets functional, performance, interoperability, deployment, upgrade, and compliance requirements.
The PQA Engineer collaborates closely with Development, Product Management, DevOps, Solution Architecture, Implementation Engineering, and Support teams to validate that VNA releases are ready for customer deployment. Responsibilities include system testing, integration testing, installation qualification, upgrade validation, defect verification, release readiness assessment, and generation of objective test evidence required by quality processes.

Key Responsibilities

Verification & Validation

  • Develop and execute Verification and Validation (V&V) strategies, plans, and test cases.

  • Validate that product requirements and user workflows are fully tested and traceable.

  • Generate objective evidence supportingreleaseapproval decisions.

  • Participate in risk-based testing activities and release readiness reviews.

System & Integration Testing

  • Perform end-to-end testing of VNA features and workflows.

  • Validate integration between application services, databases, storage components, and external healthcare systems.

  • Execute regression testing to ensure existing functionalityremainsunaffected by software changes.

  • Verify defect resolutions and perform impact assessments.

Installation & Upgrade Qualification

  • Validate new product installations.

  • Validate customer upgrade paths across supported VNA releases.

  • Verify installation and upgrade documentation for accuracy and completeness.

  • Ensure configuration settings, workflows, and customer dataremainfunctional following upgrades.

  • Participate in First Unit Build (FUB) qualification activities.

Release Qualification & Readiness

  • Support formal and informal release verification activities.

  • Assess production readiness of release candidates.

  • Identifyquality risks and communicate findings to stakeholders.

  • Collaborate with Development and DevOps teams to resolve release-blocking issues.

Performance & Scalability Validation

  • Execute performance and repeatability testing.

  • Analyze application throughput, response time, CPUutilization, memoryutilization, and system stability.

  • Identifyperformance bottlenecks and collaborate with engineering teams on corrective actions.

Documentation & Compliance

  • Create andmaintaintest plans, protocols, reports, andexecutionevidence.

  • Support traceability between requirements, test cases, andverificationresults.

  • Ensure testing activitiescomply withestablished quality processes and procedures.

  • Participate in audits and compliance reviews asrequired.

VNA-Specific Responsibilities

Medical Imaging Workflow Validation

  • Validate DICOM ingestion, storage, lifecycle management, andretrievalworkflows.

  • Verifybehaviorof patient, study, series, and image-level operations.

  • Test archive interoperability with imaging modalities, PACS, viewers, RIS, EMR, and third-party systems.

  • Validate data migration and archive consolidation workflows.

Deployment & Infrastructure Validation

  • Validate SSA, Enterprise Cluster, and other supported deployment models.

  • Verify system behavior across distributed environments.

  • Validate storage configurations, database connectivity, and platform services.

  • Execute qualification testing in customer-like deployment environments.

Upgrade & Migration Testing

  • Validate archive migrations.

  • Verify upgrade paths across supported product versions.

  • Confirm preservation of customer configurations and operational behavior after upgrades.

  • Validate disaster recovery and rollback scenarios where applicable.

Required Qualifications

Education

  • Bachelor's degree in Computer Science, Software Engineering, Information Systems, Biomedical Engineering, ora relatedtechnical field.

  • Equivalentcombination of education and experience may be considered.

Experience

  • 3+ years of software quality assurance or software testing experience.

  • Experience with system testing and integration testing of enterprise software.

  • Experience working within Agile or iterative development environments.

  • Experience creating test plans, test cases, and test execution reports.

Required Technical Skills

Quality Assurance

  • Verification & Validation (V&V)

  • Test planning and execution

  • Regression testing

  • Defect tracking and verification

  • Risk-based testing

  • Root cause analysis

Enterprise Software

  • Client-server applications

  • Distributed systems

  • Database validation and testing

  • Application deployment andupgradetesting

Tools & Processes

  • Jira

  • Test management tools

  • Requirements traceability

  • Software Development Lifecycle (SDLC)

  • Release management processes

  • Quality Management System (QMS) processes

Preferred Qualifications

Healthcare IT Experience

  • Vendor Neutral Archive (VNA)

  • PACS

  • Enterprise Imaging

  • DICOM

  • HL7

  • IHE integration profiles

  • Medical imaging workflows

Technical Expertise

  • Linux administration

  • Oracle or SQL databases

  • Web services and APIs

  • Container-based deployments

  • Test automation frameworks

  • Performance testing tools

Competencies

The successful candidatedemonstrates:

  • Strong analytical and troubleshooting skills.

  • Attention to detail and commitment to quality.

  • Ability to evaluate complete system workflows rather than isolated components.

  • Excellent written and verbal communication skills.

  • Ability to work effectively across Development, Product Management, DevOps, Professional Services, and Support organizations.

Success Criteria

A successful VNA PQA Engineer:

  • Ensuresreleases meet functional, interoperability, performance, deployment, and upgrade requirements.

  • Identifiesquality risks early in thedevelopmentlifecycle.

  • Produces audit-ready verification evidence.

  • Enables predictable, high-quality customer deployments.

  • Serves as a trusted technical quality expert for the Merge VNA platform

Compensation


The salary range provided in this job posting is intended to reflect the general market value for the position. The actual salary offered may vary based on factors such as the candidate's experience, qualifications, skills, and the specific requirements of the role. This range may also be subject to change as market conditions evolve. We encourage open communication throughout the interview process to discuss compensation expectations. For base-salary + commission sales roles, the range represents On-Target Earnings.

Min - Max :

$78,257.75 - $117,386.63 (USD)

Benefits

The benefits described represent the current offerings at our organization, however, benefits are subject to change and may vary by location and employment status. We strive to provide a comprehensive benefits package that supports our employees' health, wellness, and financial goals. Please note that benefits may be discussed in more detail during the hiring process.

  • Remote first / work from home culture

  • Flexible vacation to help you rest, recharge, and connect with loved ones

  • Paid leave benefits

  • Health, dental, and vision insurance

  • 401k retirement savings plan

  • Infertility benefits

  • Tuition reimbursement, life insurance, EAP - and more!

It is the policy of Merative to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Merative will provide reasonable accommodations for qualified individuals with disabilities.

Merative participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

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