Senior Engineer, New Product Introduction

Sonova AG•Santa Clarita, CA
•$100,320 - $125,400•Onsite

About The Position

Sonova is seeking an experienced, hands-on Senior Engineer, NPI to support new product introduction and manufacturing engineering activities in Valencia, California. The role works closely with R&D, Quality, Operations, Supply Chain, and Manufacturing to translate design requirements into robust, validated manufacturing processes. It is suited to an experienced engineer who enjoys working directly with manufacturing-floor processes, solving complex technical challenges, and independently driving projects in a highly regulated environment. The position leads manufacturing engineering and design transfer from product development through commercial manufacturing release, and develops processes, specifications, work instructions, inspection methods, acceptance criteria, and process controls for new product introductions. It also leads process characterization and validation, including IQ, OQ, and PQ, using statistical methods and Design of Experiments (DOE), and produces validation protocols, reports, and technical documentation to support manufacturing readiness. The Senior Engineer applies PFMEA and manufacturing risk analysis, collaborates with R&D and cross-functional teams on manufacturability, DFM, DFA, and traceability, and independently troubleshoots manufacturing challenges and drives measurable process improvements. The role is onsite in Valencia, California. The stated pay range is $100,320–$125,400.

Requirements

  • Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related engineering discipline.
  • At least 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.

Nice To Haves

  • Experience with laser welding, resistance welding, soldering, or electromechanical manufacturing.
  • Experience in medical device, automotive, or another highly regulated manufacturing environment is strongly preferred.

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, using statistical methods and Design of Experiments (DOE).
  • Develop 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.

Benefits

  • Medical, dental, and vision coverage.
  • Health Savings, Health Reimbursement, Flexible Spending, and Dependent Care Accounts.
  • TeleHealth options.
  • 401(k) plan with company match.
  • Company-paid life and AD&D insurance, with additional supplemental coverage available.
  • Company-paid short- and long-term disability coverage, with buy-up options available.
  • Accident and hospital indemnity coverage.
  • Legal and identity theft assistance.
  • PTO (or sick and vacation time), floating Diversity Day, and paid holidays.
  • Paid parental bonding leave.
  • Employee Assistance Program, including 24/7 mental health support, five company-paid counseling sessions, and more.
  • Internal career growth opportunities.
  • Tuition reimbursement.
  • Hearing aid discount for employees and family.
  • Internal social recognition platform.
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