Senior Manufacturing Engineer: Medical Devices & NPI

EBR Systems, Inc.

Sunnyvale (CA)

On-site

USD 122,500 - 157,500

Full time

14 days+
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Benefits offered by this job

Medical, dental, and vision insurance
401(k) matching plan
Paid Time Off – starting at 3 weeks per year
Employee stock options
Education assistance

Job summary

A medical technology company in Sunnyvale, California is seeking a Senior Manufacturing Engineer to lead product/process development and manufacturing support in the medical devices sector. The ideal candidate will have a background in mechanical or biomedical engineering, with at least 8 years of medical device manufacturing experience. This role offers a competitive salary, comprehensive benefits, and opportunities for career growth.

Qualifications

  • Minimum of 8 years of experience in medical device manufacturing.
  • Knowledge of FDA QSR and ISO13485 requirements.
  • Familiarity with catheter design and manufacturing processes.

Responsibilities

  • Contribute to product/process development and scale‑up of manufacturing.
  • Participate in projects that improve manufacturing yield and capacity.
  • Conduct root cause analysis to resolve manufacturing issues.

Skills

Mechanical engineering
Biomedical engineering
CNC laser micro welding
Root cause analysis
Lean and Six Sigma

Education

BS in Engineering discipline

Tools

CAD software
Drafting tools

Job description

A medical technology company in Sunnyvale, California is seeking a Senior Manufacturing Engineer to lead product/process development and manufacturing support in the medical devices sector. The ideal candidate will have a background in mechanical or biomedical engineering, with at least 8 years of medical device manufacturing experience. This role offers a competitive salary, comprehensive benefits, and opportunities for career growth.
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