Senior Product Safety Engineer, Medical Devices

CSA America Testing & Certification LLC; Cleveland (OH); Vor Ort; USD 92.000 - 120.000; Vollzeit

Zusammenfassung

CSA Group, a standards development and product certification organization, seeks an experienced Product Safety Engineer, Medical Devices to join our Irvine, CA office. You will lead safety certification projects for medical equipment, applying Essential Performance principles and risk management.

Join a global team focusing on safety, quality and regulatory compliance across North America. The role requires engineering experience and knowledge of CSA/UL/IEC standards.

Qualifikationen

• Bachelor's Degree in Engineering with 6+ years of related experience, or Engineering Technology with 8+ years.
• Thorough knowledge of Standards and testing procedures.
• Knowledge of CSA, UL and IEC Standards - 60601 and 61010.
• Experience with CSA certification options and services.
• Strong interpersonal, organizational, and communication skills.

Aufgaben

• Manage certification projects to meet safety requirements, timeframes, and costs.
• Review work and demonstrate technical competency in certification programs.
• Evaluate complex product types for compliance.
• Maintain multiple projects concurrently with on-time and on-budget delivery.
• Collaborate with Lab Technician to plan tests and sample counts.
• Prepare Certification Reports and Certificates of Compliance.

Kenntnisse

Interpersonal and communication skills

Customer service orientation

Organizational and time management

Read engineering drawings

Teamwork and independence

Project management

Ausbildung

Bachelor's Degree in Engineering

Tools

Microsoft Office

Laboratory equipment

Jobbeschreibung

CSA Group, a standards development and product certification organization, seeks an experienced Product Safety Engineer, Medical Devices to join our Irvine, CA office. You will lead safety certification projects for medical equipment, applying Essential Performance principles and risk management.

Join a global team focusing on safety, quality and regulatory compliance across North America. The role requires engineering experience and knowledge of CSA/UL/IEC standards.