Design Quality Engineer II

Company Overview:

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.
• Certifications: EIT Required, P.Eng preferred from EGBC. Relevant certifications (e.g., CQE, CQA) are a plus.
• 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.

• 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 - $75,213 - $101,664 (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.