Design Quality Engineer III

Verathon

  • Burnaby, BC
  • $94,929-125,147 per year
  • Permanent
  • Full-time
  • 1 month ago
Company Overview:Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company’s BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit . Overview:Verathon® is looking for a Design Quality Engineer III, to become the newest member of our QA/RA Team located in Burnaby, British Columbia.The Design Quality Engineer III is responsible for providing quality input and support for new product development and sustaining engineering teams, with an added focus on Software and Cybersecurity requirements. Additionally, the position ensures the compliance, reliability, and safety of software used in our medical devices. Responsibilities:· Support Product Lifecycle: Collaborate on new product development, design transfer to manufacturing, and sustaining engineering for VMCA product lines.· Design Control and Risk Management: Partner with product development and core teams to identify, communicate, and execute design control and risk management deliverables, such as design reviews, code reviews, defect tracking and reviews, and software validation activities for VMCA projects.· Validation Oversight: Review and ensure compliance of validation protocols and reports (IQ, OQ, PQ) for design verification and validation, adhering to internal procedures and applicable standards. Drive continuous improvement in software quality processes and methodologies.· Risk Analysis: Work with software, systems, and design engineering teams to develop and maintain Failure Modes and Effects Analyses (FMEAs).· Compliance Testing: Define and implement compliance testing requirements for VMCA products, ensuring alignment with national and international quality and conformity standards. Including, full coverage of software verification and validation (V&V) protocols, unit testing, integration testing, and system testing.· Cybersecurity Protocols: Collaborate with the software development team to establish cybersecurity protocols, including security risk assessments for VMCA products.· Quality Management System (QMS): Support the QMS to maintain effective quality assurance processes compliant with Canadian and international standards. Support internal and external audits.· Failure Investigations and CAPA: Conduct product failure investigations and support Corrective and Preventive Action (CAPA) activities. Collaborate with R&D and testing teams to identify and mitigate software defects.· Documentation: Generate compliant documentation, including risk reports, verification and validation test reports, and statistical analyses of experimental, test, and quality data.· Test & Reliability: Review experiments to assess software, component and supplier reliability, building a robust knowledge base. Work closely with software development, regulatory affairs, manufacturing, and post-market teams to ensure high-quality software delivery. Qualifications:· Education: Bachelor’s degree in science or engineering technology required; Software, Electrical, Mechanical, or Computer Science, Biomedical Engineering preferred.· Professional Certification: Professional Engineer (P.Eng) or Engineer-in-Training (EIT) eligibility required.· Experience: Minimum of 5 years of experience in a quality assurance design role, preferably within the medical device industry.· Technical Skills: Proficient in software controls with the ability to quickly learn and apply new technical skills to meet company needs. Capable of understanding and documenting code/packages, particularly for cybersecurity risk management processes.· Standards Expertise: Proficient in IEC 62304:2006 + AMD1:2015 (ed 1.1) for medical device software lifecycle requirements and IEC 81001-5-1:2021 for health software and IT systems safety, effectiveness, and security. Knowledge of ISO 13485 (including 21 CFR Part 820) and ISO 14971 as they relate to cybersecurity risk management.· Certifications: ASQ certification, such as Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE), preferred.· Regulatory Experience: Demonstrated experience in the medical device industry with familiarity in FDA, Health Canada, EU MDR, PMDA, and SFDA regulations, standards, and guidance documents (e.g., QSR 21 CFR 820, CMDR, MDD, ISO 13485, IEC 60601, ISO 10993, ISO 14971).· Communication and Problem-Solving: Strong verbal and written communication skills with the ability to apply critical thinking to identify and resolve complex problems effectively.Why Join Us?
  • Be part of an innovative team that is dedicated to improving patient outcomes.
  • Engage in meaningful work that makes a difference in the healthcare industry.
  • Competitive salary and comprehensive benefits package.
  • Salary range - $94,929 - $125,147 (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range).
  • Full-time employees who are not on a commission plan are eligible for Verathon’s annual bonus plan based on company and individual performance.
  • Verathon provides a competitive benefits package including a generous HCSA, paid holidays, paid time off and a retirement matching plan.

Verathon