Senior Design Assurance Engineer - Medical Devices (Hybrid)

Sonova Group; California; Hybrid; USD 100.000 - 150.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision

401k with company match

Life/AD&D insurance

Disability coverage

Paid time off

Parental leave

Hearing aid discount

Career growth opportunities

TeleHealth

Zusammenfassung

Sonova is seeking a Senior Design Assurance Engineer to drive compliance for Software, Firmware and Hardware in Cochlear Implant tech. You’ll partner with a multidisciplinary team to ensure design intent meets 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, MDSAP and MDR standards.

You’ll lead testing strategies, risk assessments, CAPA investigations and regulatory submissions, while mentoring teammates in a fast-paced, matrix environment. Hybrid work model and comprehensive benefits are offered.

Qualifikationen

• Bachelor’s degree in Engineering or a related technical discipline; advanced training preferred.
• Minimum 8 years in product development/design assurance, incl. 5 years with Class III devices.
• Strong knowledge of U.S. and international medical device regulations and quality systems.
• Experience working with regulatory agencies during audits.

Aufgaben

• Manage design assurance across multiple projects to meet strategic objectives.
• Lead design concept simulations under various conditions.
• Communicate progress, risks and mitigations across organization.
• Provide expertise on ISO/IEC standards and regulations.
• Ensure designs meet specifications and regulatory requirements.
• Plan and execute testing strategies including DV&V and usability.
• Lead CAPA investigations and product change analyses.
• Prepare regulatory submissions and training materials.

Kenntnisse

Regulatory knowledge

Cross-functional teamwork

Analytical skills

Problem solving

Documentation proficiency

Communication skills

English proficiency

Ausbildung

Bachelor’s degree in Engineering

Graduate degree preferred

Tools

Agile PLM

Minitab

SolidWorks

Microsoft Office

Jobbeschreibung

Sonova is seeking a Senior Design Assurance Engineer to drive compliance for Software, Firmware and Hardware in Cochlear Implant tech. You’ll partner with a multidisciplinary team to ensure design intent meets 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, MDSAP and MDR standards.

You’ll lead testing strategies, risk assessments, CAPA investigations and regulatory submissions, while mentoring teammates in a fast-paced, matrix environment. Hybrid work model and comprehensive benefits are offered.