Job description

Valencia, CA | Onsite 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. 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. Don't meet all the criteria? If you’re willing to go all in and learn we'd love to hear from you! We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources. 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&D insurance • Additional supplemental life/AD&D 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.

Requirements

Must-haves

Valencia, CA | Onsite
Senior Engineer, NPI
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.
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.
Demonstrated ability to independently lead manufacturing engineering activities, solve complex process challenges, and translate technical improvements into measurable operational or business results.
Don't meet all the criteria? If you’re willing to go all in and learn we'd love to hear from you!

Nice-to-haves

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.

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Use the role’s language and application details while tailoring your materials.

Keywords to mirror

Platform: successfactors
Effort: medium

Benefits

Benefits detected in the listing.

Dental

Vision

401k

Pto