Senior NPI Engineer — Medical Device Manufacturing

Sonova Group; Santa Clarita (CA); On-site; USD 100,000 - 125,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

Company paid life/AD&D insurance

Paid time off

Tuition reimbursement

Hearing aid discount for employees and

Employee Assistance Program

Job summary

Sonova in Valencia, CA is seeking a Senior Engineer, NPI to drive new product introductions and manufacturing readiness on the factory floor. You will collaborate with R&D, Quality, Operations, and Supply Chain to translate design requirements into validated manufacturing processes and robust controls, ensuring regulatory compliance and smooth production ramp.

The role emphasizes hands-on process development, DOE-driven validation, and risk management in a highly regulated environment with

Qualifications

• Bachelor’s degree in Mechanical/Manufacturing/Biomedical Engineering.
• 5+ years experience in Manufacturing Engineering, NPI, Process Engineering, or related field.
• Strong experience with IQ/OQ/PQ, DOE, PFMEA, and manufacturing risk management.
• Experience with manufacturing and assembly processes; laser welding, resistance welding or soldering is a plus.

Responsibilities

• Lead manufacturing engineering and design transfer activities from product development through commercial manufacturing release.
• Develop manufacturing processes, specs, work instructions, inspection methods, acceptance criteria, and process controls for new products.
• Lead process characterization and validation activities, including IQ, OQ, PQ, using DOE and statistics.
• Develop and write validation protocols, reports and technical docs to support manufacturing readiness.
• Apply PFMEA and manufacturing risk analysis to identify, evaluate and mitigate process risks.
• Partner with R&D and cross-functional teams to evaluate manufacturability, DFM, DFA, and traceability from design to production.
• Independently troubleshoot complex manufacturing challenges and drive process improvements with measurable impact.

Skills

Manufacturing Engineering

NPI

Process Validation

DOE

PFMEA

Statistical Analysis

Documentation

Troubleshooting

DFM DFA

Education

Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related

Tools

Laser Welding

Resistance Welding

Soldering

Electromechanical manufacturing

Job description

Sonova in Valencia, CA is seeking a Senior Engineer, NPI to drive new product introductions and manufacturing readiness on the factory floor. You will collaborate with R&D, Quality, Operations, and Supply Chain to translate design requirements into validated manufacturing processes and robust controls, ensuring regulatory compliance and smooth production ramp.

The role emphasizes hands-on process development, DOE-driven validation, and risk management in a highly regulated environment with