Senior Design Assurance Engineer - Medical Devices (Hybrid)

Sonova USA, Inc.; California; Hybrid; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

PTO and holidays

Tuition reimbursement

Hearing aid discount

Job summary

Sonova USA, Inc. is seeking a Senior Engineer in Design Assurance to lead QA across projects, ensuring alignment with schedule, budget, and regulatory standards. The role requires extensive testing strategy, cross-functional collaboration, and strong regulatory knowledge.

The candidate will drive compliance with ISO 14971, IEC 60601-1, and 21 CFR parts relevant to class III devices, while mentoring peers and shaping process improvements in a dynamic hybrid work environment in Valencia, CA.

Qualifications

• Bachelor's degree in Engineering; graduate degree or ASQ certification preferred.
• 8+ years product development/design assurance, incl. 5+ years with Class III devices.
• Deep knowledge of U.S. & international medical device regs (FDA, EU MDR, MDSAP).

Responsibilities

• Lead design assurance across multiple projects to meet schedule, budget and quality.
• Direct testing strategy including DV/V and human factors exploration.
• Ensure compliance with IEC 60601-1 and ISO 14971, 13485.
• Prepare regulatory submissions and CAPA investigations as needed.
• Mentor team members and train on standards and best practices.

Skills

Analytical skills

Problem solving

Communication

Cross-functional collaboration

English proficiency

Education

Bachelor's degree in Engineering

Graduate degree or ASQ certification preferred

Tools

SolidWorks CAD

Minitab

Agile PLM

Job description

Sonova USA, Inc. is seeking a Senior Engineer in Design Assurance to lead QA across projects, ensuring alignment with schedule, budget, and regulatory standards. The role requires extensive testing strategy, cross-functional collaboration, and strong regulatory knowledge.

The candidate will drive compliance with ISO 14971, IEC 60601-1, and 21 CFR parts relevant to class III devices, while mentoring peers and shaping process improvements in a dynamic hybrid work environment in Valencia, CA.