Senior R&D Quality Engineer, Medical Devices

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D

Disability insurance

401(k) with employer match

Parental leave

Company holidays

Vacation days

Sick leave

Job summary

Penumbra, Inc. in California is seeking a Senior R&D Quality Engineer (Development) to lead quality engineering on product development teams, designing and qualifying life-saving medical devices.

You will implement design controls and support FDA readiness while guiding projects through detailed phases of engineering and testing. The role requires 5+ years in Quality Assurance within regulated environments, strong auditing and design-review experience, and proficiency with MS

Qualifications

• 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
• Advanced degree preferred
• Experience in auditing, design review, sterilization, project management, and/or product development highly desired
• Demonstrated knowledge of engineering and scientific principles
• High proficiency with computers and software applications
• Medical device, pharmaceutical, biotech, and/or other regulated industry experience desired
• Strong oral, written, and interpersonal communication skills
• High degree of accuracy and attention to detail
• Proficiency with MS Word, Excel, and PowerPoint
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Responsibilities

• Lead 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 engineering work for projects with various scopes.
• 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 requirements per regulatory and industry standards
• Support developmental projects in the area of quality engineering
• Analyze reports and recommend corrective and preventive action to adverse results.
• Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications.
• Support activities during FDA inspections and notified body audits.
• Participate in the development of standard operating procedures.
• Develop and approve documentation for inspection/testing procedures.
• Perform responsibilities required by the Quality System and other duties as assigned.
• 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.

Skills

Quality Assurance

ISO

Auditing

Design reviews

Project management

Product development

Regulatory compliance

Communication

MS Word/Excel/PowerPoint

Education

Bachelor’s degree in Engineering, a Life Science or related field

Advanced degree preferred

Tools

MS Word

Excel

PowerPoint

Job description

Penumbra, Inc. in California is seeking a Senior R&D Quality Engineer (Development) to lead quality engineering on product development teams, designing and qualifying life-saving medical devices.

You will implement design controls and support FDA readiness while guiding projects through detailed phases of engineering and testing. The role requires 5+ years in Quality Assurance within regulated environments, strong auditing and design-review experience, and proficiency with MS