Senior Quality Engineer - Metals

Penumbra, Inc.; Alameda (CA); On-site; USD 125,000 - 175,000; Full time

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Senior Quality Engineer to support manufacturing operations for medical devices. You will utilize strong analytical and problem-solving skills to enhance quality and improve processes during production phases.

The role requires extensive experience in quality engineering and working knowledge of FDA QSR and ISO 13485. Candidates should have a Bachelor's degree in Engineering and be prepared to lead investigations and continuous improvements across inspection systems.

Qualifications

• 5+ years of experience in Quality Engineering or Manufacturing Engineering in the medical device industry.
• Experience supporting manufacturing operations, process development, or NPI.
• Working knowledge of FDA QSR and ISO 13485 in a manufacturing environment.

Responsibilities

• Provide Quality Engineering support for assigned products and production lines.
• Lead complex root cause investigations using structured problem-solving tools.
• Champion and improve inspection strategies, including in-process and final inspections.

Skills

Data analysis

Problem solving

Decision making

Lean methodologies

Six Sigma

Education

Bachelor's degree in Engineering

Tools

Statistical sampling methods

Quality system activities

Job description

General Summary

As a Senior Quality Engineer, you will support manufacturing operations and production lines for a range of medical devices. You will apply strong analytical and problem-solving skills to maintain process control, strengthen inspection and monitoring systems, and contribute to yield and quality improvements from early commercial ramp through mature production. This role requires strong independent judgment, technical depth, and the ability to evaluate, adapt, and apply standard engineering and quality practices to complex manufacturing challenges. You will plan and conduct work with independence, devise new approaches to problems, and contribute to the development, application, and continuous improvement of quality standards within Operations. Working closely with Manufacturing Engineering, Production, and Industrial Engineering to ensure quality is built into every stage of the manufacturing process.

Specific Duties and 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

Position Qualifications

Minimum education and experience:

• Bachelor's degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related discipline preferred)
• 5+ years of experience in Quality Engineering or Manufacturing Engineering within the medical device industry
• Experience supporting manufacturing operations, process development, or NPI
• Working knowledge of FDA QSR and ISO 13485 in a manufacturing environment
• Strong data analysis, problem solving, and decision making skills

Preferred Experience

• CQE certification or related training
• Experience supporting high volume manufacturing and early commercial yield ramp
• Background in inspection systems, destructive testing, and statistical sampling methods
• Experience managing projects or coordinating cross functional project activities
• Experience with Measurement System Analysis (MSA) and Six Sigma Black Belt projects
• Experience collaborating with Production, Industrial Engineering, and Equipment Engineering teams
• Versatility, flexibility, and willingness to work within a dynamic environment

Working Conditions

• General office, laboratory, and cleanroom environments.
• Business travel from 0% - 10%.
• Potential exposure to blood-borne pathogens.
• Requires some lifting and moving of up to 25 pounds.
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Location and Pay

• Alameda, CA
• $125,000 to $175,000

Equal Employment Opportunity

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.