Sr. Quality Electrical Engineer (Medical Device Experience Required)

General Summary

The Sr Quality Electrical Engineer role is for a fully qualified engineer in all conventional aspects and functional areas. Plan and conduct work requiring judgment and independent evaluation along with selection and adaptation or modification of standard techniques, procedures, and criteria. Devise new approaches to problems encountered. Develop quality standards, application, revision, and maintenance for manufacturing. Monitor design control and provide quality assurance support. Work independently with general instructions toward the objectives expected. Receive technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Communicate and implement quality objectives.

Specific Duties and 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 PCB function verification to ensure all functions meet design specifications, validating critical parameters such as power and signal integrity margins
• Maintain and track critical hardware PCB issues, document findings, and ensure effective communication with relevant stakeholders
• 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.
• Indicates an essential function of the role

Position Qualifications

Minimum education and experience :

Additional qualifications :

Working Conditions

Location and Pay

What We Offer

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

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.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.