Nitinol NPI Manufacturing Engineer II

Resonetics

San Diego (CA)

On-site

USD 65,000 - 102,000

Full time

7 days ago
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Job summary

Resonetics seeks a Manufacturing Engineer II, NPI to drive the introduction and industrialization of Nitinol-based manufacturing technologies. You will bridge Process Development, Quality, and Production on floor-level implementations and early production ramp-ups.

The role emphasizes hands-on problem solving, process validation (IQ/OQ/PQ), and data-driven improvements to enable robust transfer and scalable manufacturing in a fast-paced life sciences setting.

Qualifications

  • Minimum 3 years in engineering within a manufacturing setting, ideally supporting NPI or process transfer.
  • Bachelor’s degree in Mechanical or Industrial Engineering or related field.
  • Strong ability to generate, maintain process documentation and validation reports.
  • Experience in regulated manufacturing environments and quality system requirements.

Responsibilities

  • Support transfer of new products and processes from Development to Production with readiness and product integrity.
  • Establish Nitinol-based manufacturing processes including laser and inspection operations.
  • Execute IQ/OQ/PQ validations and TMVs to ensure robust process validation.
  • Develop and maintain WIs, routers, and process documentation for transfer.
  • Contribute to initial job cost baselines, cycle times, and ERP standards.

Skills

Technical writing
Regulatory environment knowledge
Lean manufacturing
Data analysis mindset

Education

Bachelor’s degree in Mechanical or Industrial Engineering

Tools

Excel
Power BI
Minitab
CAD / SolidWorks

Job description

Resonetics seeks a Manufacturing Engineer II, NPI to drive the introduction and industrialization of Nitinol-based manufacturing technologies. You will bridge Process Development, Quality, and Production on floor-level implementations and early production ramp-ups.

The role emphasizes hands-on problem solving, process validation (IQ/OQ/PQ), and data-driven improvements to enable robust transfer and scalable manufacturing in a fast-paced life sciences setting.

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