Penumbra, Inc. · 4 hours ago
Quality Engineering Manager
Alameda, CA
Full-time
Onsite
Senior Level
$145K/yr - $214K/yr
5+ years expPenumbra, Inc. is a global healthcare company focused on innovative therapies. In this role, you will lead a team of Quality Engineers to ensure manufacturing quality performance and implement inspection strategies for medical devices.
Medical Device
Responsibilities
Lead Quality Engineering support for assigned product portfolios and production lines
Serve as the primary quality partner to Production, Manufacturing Engineering, and Industrial Engineering
Own manufacturing quality performance, including yield, scrap, productivity, and throughput-related quality losses
Own and advance inspection strategies, including in-process and final inspection, destructive testing, sampling plans, and acceptance/reject criteria
Drive continuous improvement of inspection systems, test methods, process monitoring, and digital quality tools
Apply Lean and Six Sigma methodologies to improve yield, reduce waste, and enhance process capability
Own execution of quality system activities within Operations, including NCRs, MRB, CAPAs, control chart investigations, and effectiveness verification
Champion process-based risk management, including pFMEAs and defining CTQs
Review and approve equipment-related quality activities, including equipment qualifications (IQ/OQ), equipment-related ECOs, non-standard maintenance activities, and equipment software validation, in partnership with Manufacturing Engineering
Hire, develop, and manage Quality Engineers, including workload and FTE planning to support production priorities
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
1+ years of leadership experience required; people management experience preferred
Previous manufacturing engineering, process development, or NPI experience preferred
Working knowledge of FDA QSR and ISO 13485 in a manufacturing environment
Prior people leadership experience or demonstrated readiness to manage and develop engineers
Strong data analysis, problem-solving, and decision-making skills
Preferred
Product Quality Engineering support for catheterization delivery systems and/or nitinol-based devices
Experience supporting high-volume manufacturing and early commercial yield ramp
Strong background in inspection systems, destructive testing, and statistical sampling methods
Versatility, flexibility, and willingness to work within a dynamic environment
Practical application of Lean and Six Sigma in manufacturing or quality environments
Experience partnering closely with Production, Industrial Engineering, and Equipment Engineering teams
CQE certification or training
Experience with data systems (e.g. PowerBI or Tableau), statistical analysis, and design of experimentation
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