Design Quality Engineer II

at  Verathon

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 www.verathon.com.
Overview:
As a Design Quality Engineer, you will play a crucial role in supporting the quality aspects of new product development and sustaining engineering initiatives. You will work closely with cross-functional teams to ensure that all quality standards are met throughout the product lifecycle.

Responsibilities:

• Quality & Risk Management: Lead and create quality plans, risk management plans, risk management reports, system risk assessments (SRA), software risk assessments, and cybersecurity risk assessments.
• Validation Review: Evaluate validation protocols and reports for design verification and validation activities (IQ, OQ, PQ), ensuring compliance with internal procedures and governing standards.
• Collaboration: Partner with product development engineering and core teams to identify, communicate, and drive the execution of design control and risk management deliverables across various projects.
• Compliance Testing: Establish compliance testing requirements aligned with national and international quality and conformity standards, fostering collaboration among teams.
• Failure Mode Analysis: Work with systems and design engineering to develop and sustain Failure Modes and Effects risk analyses (u & d FMEAs).
• Product Lifecycle Support: Support product lines throughout new product development, facilitate design transfer to manufacturing, and assist in sustaining engineering efforts.
• Quality Management System: Enhance the Quality Management System to uphold effective quality assurance processes and ensure compliance with various Canadian and International Standards.
• Failure Investigations: Conduct thorough product failure investigations and oversee CAPA-related activities.
• Documentation Production: Generate compliant documents such as risk reports, verification, and validation test reports, including statistical analyses of experimental, test, and quality data, along with receiving inspection requirements documents and post-market surveillance plans.
• Cybersecurity Protocols: Define cybersecurity protocols, including security risk assessments related to products, collaborating closely with the software development team.
• Experimental Design: Design and execute experiments to enhance understanding of component and supplier process reliability.

Qualifications:

• Education: Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or a related field). A Master’s degree is a plus.
• Experience: Minimum of 2 years of experience in quality engineering, particularly in medical devices or related fields.
• Technical Skills: Familiarity with design control processes, risk management methodologies, and quality management systems.
• Regulatory Knowledge: Knowledge of relevant regulatory standards (ISO, FDA) is essential.
• Analytical Skills: Strong analytical and problem-solving skills, with proficiency in statistical analysis.
• Communication Skills: Excellent verbal and written communication skills to effectively collaborate with cross-functional teams.
• Certifications: EIT Required, P.Eng preferred from EGBC. Relevant certifications (e.g., CQE, CQA) are a plus.

• Quality & Risk Management: Lead and create quality plans, risk management plans, risk management reports, system risk assessments (SRA), software risk assessments, and cybersecurity risk assessments.
• Validation Review: Evaluate validation protocols and reports for design verification and validation activities (IQ, OQ, PQ), ensuring compliance with internal procedures and governing standards.
• Collaboration: Partner with product development engineering and core teams to identify, communicate, and drive the execution of design control and risk management deliverables across various projects.
• Compliance Testing: Establish compliance testing requirements aligned with national and international quality and conformity standards, fostering collaboration among teams.
• Failure Mode Analysis: Work with systems and design engineering to develop and sustain Failure Modes and Effects risk analyses (u & d FMEAs).
• Product Lifecycle Support: Support product lines throughout new product development, facilitate design transfer to manufacturing, and assist in sustaining engineering efforts.
• Quality Management System: Enhance the Quality Management System to uphold effective quality assurance processes and ensure compliance with various Canadian and International Standards.
• Failure Investigations: Conduct thorough product failure investigations and oversee CAPA-related activities.
• Documentation Production: Generate compliant documents such as risk reports, verification, and validation test reports, including statistical analyses of experimental, test, and quality data, along with receiving inspection requirements documents and post-market surveillance plans.
• Cybersecurity Protocols: Define cybersecurity protocols, including security risk assessments related to products, collaborating closely with the software development team.
• Experimental Design: Design and execute experiments to enhance understanding of component and supplier process reliability