Sr. Quality Electrical Sustaining Engineer

Sr. Quality Electrical Sustaining Engineer

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This range is provided by Penumbra, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

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.

• 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.*
• 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.*
• 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

• Minimum education and experience:
  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 devices’ or regulated industry environment.
• Advanced degree preferred.
• 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.

• 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…