Design Quality Engineer Ii

Company OverviewVerathon
is a global medical device company committed to being a trusted partner to our customers and advancing patient care through innovative Airway Management and Urology solutions. For more than 40 years, we have worked alongside healthcare professionals to understand their needs and deliver high-quality technologies that provide lasting clinical and economic value.
Our portfolio includes leading GlideScope ® video laryngoscopy and BFlex™ bronchoscopy solutions, BladderScan ®
bladder volume measurement, and a growing range of single-use Urology solutions. Behind our innovations is a diverse, global team united by a commitment to our customers, collaboration, and improving patient care.
Verathon, a business unit of Roper Technologies, is headquartered in Bothell, Washington, with international subsidiaries in Canada, Europe, and Asia Pacific.
OverviewAs a Design Quality Engineer II, 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.Join our dynamic team in Burnaby, British Columbia, and contribute to our mission of delivering quality healthcare solutions.
Responsibilities
Quality & Risk Management : Proactively develop and implement robust quality plans, risk management strategies, risk management reports, system risk assessments (SRA), software risk assessments, and cybersecurity risk assessments to ensure compliance and mitigate potential issues.
Validation Leadership : Rigorously review and approve validation protocols and reports for design verification and validation activities (IQ, OQ, PQ), driving adherence to internal procedures and regulatory standards.
Cross-Functional Collaboration : Actively partner with product development engineering and core teams to identify, communicate, and execute design control and risk management deliverables, fostering seamless collaboration across multiple projects.
Compliance Testing Excellence : Define and champion compliance testing requirements aligned with national and international quality and conformity standards, promoting teamwork and consistency across departments.
Failure Mode Analysis : Collaborate closely with systems and design engineering teams to create, maintain, and enhance Failure Modes and Effects Analyses (uFMEA and dFMEA) to proactively address risks.
Product Lifecycle Ownership : Drive product success by supporting new product development, leading design transfer to manufacturing, and bolstering sustaining engineering efforts throughout the product lifecycle.
Quality Management System Enhancement : Continuously improve the Quality Management System to strengthen quality assurance processes and ensure compliance with Canadian and international standards.
Failure Investigations & CAPA Leadership : Lead comprehensive product failure investigations and spearhead Corrective and Preventive Action (CAPA) initiatives to resolve issues and prevent recurrence.
Documentation Excellence : Produce high-quality, compliant documentation, including risk reports, verification and validation test reports, statistical analyses of experimental and quality data, receiving inspection requirements, and post-market surveillance plans.
Cybersecurity Innovation : Establish and refine cybersecurity protocols, including product-related security risk assessments, in close collaboration with the software development team to ensure robust protection.
Experimental Design & Reliability : Design and conduct strategic experiments to deepen insights into component and supplier process reliability, driving continuous improvement.
Qualifications
Education : Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or a related field). A Master’s degree is a plus.
Professional Certification : Professional Engineer (P.Eng) or Engineer-in-Training (EIT) eligibility required.
Experience : Minimum of 3 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, IEC, 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 : Relevant certifications (e.G., CQE, CQA) are a plus.
Benefits of Working with Us
Base Salary :Range of$81,444 - $108,110 (Compensation will vary based on skills, experience and location;
it is not typical to behired at or above the top of the salary range).
Additional Earning Potential :Full-time employees who are not on a commission plan are eligible for Verathon’s annual bonus plan based on company and individual performance.
Wellness & Life Balance Programs :Competitive benefits package including a generous HCSA, paid holidays, paid time off, and a retirement matching plan.
Growth & Development :Professional development programs, internal promotions, certification courses, and tuition reimbursement.
Fun & Employee Engagement : Team appreciation events, team building activities and celebrations with a culture centered on employee engagement.
EEOVerathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success. In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Verathon will be based on merit, qualifications, and abilities. Verathon does not discriminate in employment opportunities or practices on the basis of race, color, religion, sexual orientation, gender identity, national origin, age, disability, or any other characteristic protected by law.
#J-18808-Ljbffr