Medical Device Senior Quality Engineer

Penumbra, Inc.; San Francisco (CA); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

401(k)

Job summary

Penumbra, Inc. seeks a Sr. Quality Engineer to lead quality assurance efforts for medical devices in a regulated environment.

You will develop quality standards, monitor design control, and support FDA inspections while collaborating with cross-functional teams. The role emphasizes hands-on qualification activities, documenting findings, and driving corrective actions. A strong background in ISO practices, auditing, and project management is required, with 5+ years in medical devices or

Qualifications

• Bachelor’s degree in Engineering or Life Science with 5+ years of QA/regulatory experience.
• Advanced degree preferred.
• Experience auditing, design review, sterilization, project management and product development.
• Experience with Electronic devices and PCBAs.

Responsibilities

• Participate in development and qualification activities for new and existing products.
• Lead and participate in project teams coordinating quality efforts to design, develop, and improve products.
• Maintain and track hardware PCB issues and communicate with stakeholders.
• Perform engineering work including design verification and testing methods.
• Develop and validate measurement methods and monitor design control and regulatory standards.
• Analyze reports and returned products and recommend corrective/preventive actions.
• Perform statistical analysis and assign responsibility for non-conforming items.
• Participate in NCR or CAPA boards and assist in QSR training.
• Support FDA inspections and notified body audits and develop SOPs.
• Adhere to QMS and security/compliance principles; manage staff development.

Skills

Quality Assurance

Auditing

Project management

Design review

Statistical analysis

Education

Bachelor’s degree in Engineering or Life Science

Advanced degree preferred

Tools

PCB design/assembly knowledge

Job description

The Sr. Quality 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. *
• 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. *
• 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:

• 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

Working Conditions

• 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 floors.
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Location and Pay

$125,000 to $175,000

What We Offer

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes 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, and paid sick time in compliance with applicable law(s).

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.