Sr. Development Quality Engineer

Regulatory Toolkit; Alameda (CA); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Benefits package

Equity program

Paid vacation & holidays

Job summary

Penumbra, Inc. in Alameda, CA seeks a Senior Development Quality Engineer to lead Quality Engineering for new life-saving medical devices.

You will design controls, qualify products, and ensure compliance with FDA and ISO standards across design, manufacturing, and inspection. Reporting to the Quality leadership, you will drive improvements, develop measurement methods, support FDA inspections and audits, and mentor teams in quality systems while advancing innovative therapies.

Qualifications

• Bachelor’s degree in Engineering or Life Science with 5+ years QA/ISO experience.
• Experience auditing, design reviews, sterilization, and project management.
• Strong communication and documentation skills.
• Medical device or regulated industry background desired.
• Advanced degree preferred.

Responsibilities

• Lead development and qualification activities for new and existing products.
• Coordinate quality efforts across project teams to design, develop, and improve products.
• Inspect, test, and evaluate equipment; develop measurement methods.
• Ensure designs meet QMS, FDA, and ISO requirements.
• Support FDA inspections and notified body audits.
• Develop SOPs and documentation for inspection/testing.

Skills

Auditing

Design review

Sterilization

Project management

Product development

Education

Bachelor’s degree in Engineering

Advanced degree preferred

Tools

MS Word

Excel

PowerPoint

Job description

General Summary

The Senior Development Quality Engineer leads Quality Engineering responsibilities as part of a product development team to design and qualify new life-saving products. This 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 design, manufacturing, and inspection. Implement design control requirements and provide quality engineering 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

• 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. *
• 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 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.

*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

Additional qualifications:

• 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

Location and Pay

Alameda, CA

Annual Base Salary Range: $125,000 to $175,000

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

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.

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 toPenumbra's Privacy Notice for California Residents.

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