Senior Engineer, New Product Introduction
Sonova AG
Summary
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.
Job description
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.
Requirements
- 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
Benefits
- Medical, Dental & Vision
- Health Savings Account
- Health Reimbursement Account
- Flexible Spending Account
- Dependent Care Account
- Telehealth Options
- 401(k) Matching
- Life & AD&D Insurance
- Short & Long-Term Disability
- Accident & Hospital Indemnity
- Legal & ID Theft Assistance
- Paid Time Off
- Paid Holidays
- Paid Parental Bonding Leave
- Employee Assistance Program
- Tuition Reimbursement
- Hearing Aid Discount
Company overview
Sonova Holding AG is a globally recognized Swiss medical device company specializing in innovative hearing care solutions. Founded in 1947 and headquartered in Stäfa, Switzerland, Sonova has established itself as one of the world's largest providers in the hearing care sector, holding approximately 24% of the global hearing aid market. The company operates through four core business divisions: Hearing Instruments, Audiological Care, Consumer Hearing, and Cochlear Implants. Sonova's diverse portfolio includes renowned brands such as Phonak, Unitron, Advanced Bionics, AudioNova, and licensed Sennheiser products. With over 17,990 employees worldwide, the company generates annual revenues exceeding CHF 3.6 billion and serves customers in more than 100 countries. Sonova's comprehensive offerings range from digital hearing aids and cochlear implants to wireless communication systems and professional audiological care services. As a component of the Swiss Market Index, Sonova maintains research facilities in Switzerland, Canada, and the United States, with manufacturing plants strategically located across Switzerland, China, and Vietnam. The company's mission centers on enabling people to experience the joy of hearing and live life without limitations through cutting-edge audio technology and comprehensive hearing care solutions.