Penumbra, Inc. · 16 hours ago
Senior Quality Engineer (Medical Device)
San Francisco Bay Area
Full-time
Onsite
Mid, Senior Level
$125K/yr - $175K/yr
5+ years expPenumbra, Inc. is a global healthcare company focused on innovative therapies. As a Senior Quality Engineer, you will support manufacturing operations for medical devices, applying analytical skills to maintain process control and improve quality standards throughout production.
Medical Device
Hiring Manager
Dexter Whack
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
Qualification
Required
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
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
Benefits
Medical
Dental
Vision
Life
AD&D
Short and long-term disability insurance
401(k) with employer match
Paid parental leave
Eleven paid company holidays per year
A minimum of fifteen days of accrued vacation per year, which increases with tenure
Paid sick time in compliance with applicable law(s)
Company
Penumbra, Inc.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.
1001-5000 employees
H1B Sponsorship
Penumbra, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (36)
2024 (42)
2023 (46)
2022 (43)
2021 (36)
2020 (26)
Funding
Current Stage
Late StageLeadership Team
Adam Elsesser
CEO
Frances Palmer-Smith
Chief Trust Officer
Recent News
Med-Tech Innovation
2024-05-05
Company data provided by crunchbase