Senior NPI Engineer: Manufacturing Transfer & Validation

Sonova USA, Inc.; California; On-site; USD 100,000 - 125,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

Hearing aid discount for employees and

Tuition reimbursement

Job summary

Sonova USA, Inc. in Valencia, CA is seeking a hands-on Senior Engineer, NPI to spearhead new product introduction and manufacturing engineering activities on onsite operations.

You will collaborate with R&D, Quality, Operations, Supply Chain and Manufacturing to translate design requirements into validated production processes, driving improvements in a highly regulated environment. The role emphasizes process validation, design transfer, and strong technical writing, with opportunities to

Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field.
• 5+ years of experience in Manufacturing Engineering, NPI, Process Engineering, design transfer, or related field.
• Strong experience with process validation, including IQ/OQ/PQ, DOE, statistical analysis, PFMEA, and manufacturing risk management.
• Strong technical and documentation writing skills, including validation protocols and reports.
• Experience with laser welding, resistance welding, soldering, or electromechanical manufacturing is a plus.

Responsibilities

• Lead manufacturing engineering and design transfer activities from product development through commercial manufacturing release.
• Develop manufacturing processes, specifications, work instructions, inspection methods, acceptance criteria, and process controls for new product introductions.
• Lead process characterization and validation activities, including IQ, OQ, and PQ, utilizing statistical methods and Design of Experiments (DOE).
• Develop and write validation protocols, reports, and technical documentation required 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 requirements through validated production processes.
• Independently troubleshoot complex manufacturing challenges and drive process improvements with measurable results.

Skills

Manufacturing Engineering

NPI

Process Engineering

Design Transfer

DOE & Statistics

Education

Bachelor's degree in Mechanical Engineering or related

Tools

PFMEA

IQ/OQ/PQ

Job description

Sonova USA, Inc. in Valencia, CA is seeking a hands-on Senior Engineer, NPI to spearhead new product introduction and manufacturing engineering activities on onsite operations.

You will collaborate with R&D, Quality, Operations, Supply Chain and Manufacturing to translate design requirements into validated production processes, driving improvements in a highly regulated environment. The role emphasizes process validation, design transfer, and strong technical writing, with opportunities to