Senior NPD Quality Engineer – Drive LifeSaving Medical Tech

Regulatory Jobs; Irvine (CA); Sur place; USD 121 000 - 171 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Incentives

Benefits program

Résumé du poste

Regulatory Jobs in California seeks a senior Quality Engineer to oversee design control documentation, risk management, and usability files within a robust quality system supporting medical device development. You will partner with engineers, clinicians, and cross-functional teams to ensure regulatory alignment and patient safety throughout the lifecycle.

Ideal candidates bring strong leadership, CAD experience, MS Office proficiency, and a deep understanding of quality engineering and

Qualifications

• Bachelor's Degree in Engineering or Science with 6 years' experience.
• Master's Degree or equivalent with 5 years' experience.
• PhD or equivalent with 2 years' experience.

Responsabilités

• Provide leadership to develop design control documentation across product development processes.
• Develop, update, and maintain risk management and usability files.
• Lead optimization of Manufacturing and R&D processes using engineering methods for design for manufacturing and continuous improvement.
• Drive development and execution of complex experiments and tests to create, validate, and improve products and establish robust test methods.
• Lead investigation of complex quality and compliance issues and support regulatory submissions and audits.
• Train and coach engineers/technicians on procedures and testing.
• Oversee Quality support tasks and collaboration across teams.

Connaissances

Design control

Risk management

Leadership

Problem solving

Interpersonal/communication

Formation

Bachelor's Degree in Engineering or Science

Master's Degree or equivalent

Ph.D. in Engineering or Science

Outils

MS Office Suite

CAD

Quality systems

Description du poste

Regulatory Jobs in California seeks a senior Quality Engineer to oversee design control documentation, risk management, and usability files within a robust quality system supporting medical device development. You will partner with engineers, clinicians, and cross-functional teams to ensure regulatory alignment and patient safety throughout the lifecycle.

Ideal candidates bring strong leadership, CAD experience, MS Office proficiency, and a deep understanding of quality engineering and