Penumbra, Inc. · 2 weeks ago
Sr Quality Engineer - Electronics
Alameda, CA
Full-time
Onsite
Mid, Senior Level
$125K/yr - $175K/yr
5+ years expPenumbra, Inc. is a global healthcare company focused on innovative therapies. They are seeking a Senior Quality Engineer to develop quality standards, monitor design control, and provide quality assurance support for manufacturing processes.
Medical Device
Responsibilities
Participate in the development and qualification activities for new and existing products
Lead and participate in project teams coordinating the quality efforts to design, develop, and continuously improve products. Plan, schedule, conduct, or coordinate detailed phases of the engineering work for projects with various scopes
Perform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements
Perform engineering work including one or more of the following:
Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment
Develop and validate measurement methods
Monitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control standards per regulatory and industry standards
Support developmental projects in the area of quality assurance
Analyze reports and returned products and recommend corrective and preventive action
Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications
Participate in NCR or CAPA board as necessary
Assist in and perform QSR training
Support activities during FDA inspections, FDB inspections, and notified body audits
Participate in the development of standard operating procedures
Prepare documentation for inspection/testing procedures
Perform responsibilities required by the Quality System and other duties as assigned
Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company
Ensure other members of the department follow the QMS, regulations, standards, and procedures
Perform other work-related duties as assigned
Qualification
Required
Bachelor's degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience, preferably in a medical device or regulated industry environment
Preferred
Advanced degree preferred
Experience applying IEC 60601 standards in a medical device environment preferred
Experience with Process Failure Mode and Effects Analysis (PFMEA), sustaining projects, commercial medical device manufacturing, Non-Conformance Reports (NCRs), Failure Investigations, and Change Control
Experience in auditing, design review, sterilization, project management, and/or product development highly desired
Experience with Electronic devices and or PCBAs
Experience with Contract Manufactured Electromechanical Medical device products
Benefits
Medical
Dental
Vision
Life
AD&D
Short and long-term disability insurance
401(k) with employer match
An employee stock purchase plan
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