Senior Quality Engineer - Metals for Medical Devices

Penumbrainc; Alameda (CA); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

AD&D

Disability Insurance

401(k) Matching

Parental Leave

Paid Holidays

Vacation accrual

Paid Sick Time

Job summary

Penumbrainc in Alameda, CA is seeking a Senior Quality Engineer to support manufacturing operations for a range of medical devices. You will apply analytical skills to maintain process control, strengthen inspection systems, and drive quality improvements from early ramp to mature production.

Collaborating with Manufacturing Engineering, Production, and Industrial Engineering, you will lead root cause investigations, monitor quality performance, and apply Lean/Six Sigma to reduce waste and

Qualifications

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related).
• 5+ years of experience in Quality or Manufacturing Engineering in the medical device industry.
• Experience with FDA QSR and ISO 13485 in a manufacturing environment.

Responsibilities

• Provide Quality Engineering support for assigned products and production lines.
• Act as a key quality partner to Production, Manufacturing Engineering, and Industrial Engineering.
• Lead complex root cause investigations using structured problem solving tools (5 Why, Fishbone, DOE, regression analysis).
• Support monitoring of manufacturing quality performance, including yield, scrap, and process capability.
• Champion and improve inspection strategies, including in process and final inspection, destructive testing, sampling plans, and acceptance criteria.
• Lead continuous improvement of inspection systems, test methods, process monitoring, and digital quality tools.
• Apply Lean and Six Sigma methodologies to reduce waste and improve process capability.
• Execute quality system activities within Operations, including NCRs, MRB, CAPAs, control chart investigations, and effectiveness verification.
• Conduct and maintain pFMEAs, ensuring risks are mitigated through appropriate controls and monitoring.
• Support early commercial ramp-up, material or process changes, and site transfers.

Skills

Data analysis

Problem solving

Decision making

Education

Bachelor's degree in Engineering

Job description

Penumbrainc in Alameda, CA is seeking a Senior Quality Engineer to support manufacturing operations for a range of medical devices. You will apply analytical skills to maintain process control, strengthen inspection systems, and drive quality improvements from early ramp to mature production.

Collaborating with Manufacturing Engineering, Production, and Industrial Engineering, you will lead root cause investigations, monitor quality performance, and apply Lean/Six Sigma to reduce waste and