Senior Engineer, New Product Introduction

Sonova Group; Santa Clarita (CA); Vor Ort; USD 100.000 - 125.000; Vollzeit

Benefits dieser Stelle

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

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Manufacturing Engineering

NPI

Process Validation

DOE

PFMEA

Statistical Analysis

Documentation

Troubleshooting

DFM DFA

Ausbildung

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

Tools

Laser Welding

Resistance Welding

Soldering

Electromechanical manufacturing

Jobbeschreibung

Senior Engineer, NPI

We are looking for an experienced, hands-on Senior Engineer, NPI to support new product introduction and manufacturing engineering activities in Valencia, California. In this role, you will work closely with R&D, Quality, Operations, Supply Chain, and Manufacturing to translate design requirements into robust, validated manufacturing processes. This is an ideal opportunity for an experienced engineer who enjoys working directly with manufacturing-floor processes, solving complex technical challenges, and independently driving projects in a highly regulated environment.

Valencia, CA | Onsite

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, Design for Manufacturability (DFM), Design for Assembly (DFA), and traceability from design requirements through validated production processes.
• Independently troubleshoot complex manufacturing challenges and drive process improvements that deliver measurable operational and business results.

More about you

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related engineering discipline.
• 5+ years of experience in Manufacturing Engineering, NPI, Process Engineering, design transfer, or a 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 experience developing validation protocols and reports.
• Experience working with manufacturing and assembly processes. Experience with laser welding, resistance welding, soldering, or electromechanical manufacturing is a plus.
• Experience in medical device, automotive, or another highly regulated manufacturing environment is strongly preferred.
• Demonstrated ability to independently lead manufacturing engineering activities, solve complex process challenges, and translate technical improvements into measurable operational or business results.

What we offer

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match*
• Company paid life/AD&DD insurance
• Additional supplemental life/AD&DD coverage available
• Company paid Short/Long-Term Disability coverage (STD/LTD)
• STD/LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
• Paid parental bonding leave
• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
• Robust Internal Career Growth opportunities
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform

Plan rules/offerings dependent upon group Company/location.

This role's pay range is between: $100,320 - $125,400.

How we work

At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

Sonova is an equal opportunity employer

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place.

We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.