Senior Quality Electrical Engineer - Medical Devices

General Summary

Join our innovative team as a Senior Quality Electrical Engineer, where you'll play a vital role in enhancing medical device quality standards. In this fully qualified position, you'll conduct and lead engineering tasks requiring independent evaluation, adaptation of techniques, and innovative problem-solving approaches. Your expertise will be crucial in establishing and maintaining quality standards in manufacturing, monitoring design control, and delivering essential quality assurance support.

Specific Duties and Responsibilities

• Lead and contribute to the development and qualification activities for both new and existing medical products.
• Coordinate with project teams to ensure quality integration during the design, development, and continuous improvement phases.
• Validate PCB functions against design specifications while ensuring power and signal integrity margins.
• Document and track critical PCB hardware issues, providing effective updates to all stakeholders.
• Engage in engineering tasks that may involve intricate design requirements and coordination challenges.
• Develop inspection, testing, and evaluation methods for equipment precision and accuracy.
• Establish and validate measurement methodologies.
• Monitor design control compliance with regulatory and industry standards, maintaining success measurement systems.
• Support development projects with a focus on quality assurance.
• Analyze product reports and returns, recommending corrective and preventive measures.
• Perform statistical analyses to determine accountability for products not meeting standards.
• Contribute to Non-Conformance Report (NCR) and Corrective and Preventive Action (CAPA) boards as necessary.
• Facilitate Quality System Regulation (QSR) training.
• Assist during FDA inspections, FDB inspections, and notified body audits.
• Develop standard operating procedures and prepare documentation for testing and inspection processes.
• Manage and develop team members, providing ongoing feedback and performance reviews.
• Adhere strictly to our Quality Management System (QMS) and all relevant quality regulations.
• Encourage compliance within the department regarding QMS and regulations.
• Perform other responsibilities as assigned.

Position Qualifications

Working Conditions

Location and Pay

Headquartered in Alameda, CA. Salary range : $125,000 to $175,000.

What We Offer

Become part of a collaborative team focused on continuous learning and performance rewards. Join us in revolutionizing treatments for some of the world's most challenging medical conditions. We offer a generous benefits package, which includes medical, dental, vision, life, AD&D, disability insurance, a 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid holidays per year, a minimum of fifteen days of accrued vacation that increases with tenure, and paid sick leave in compliance with applicable laws.

Penumbra, Inc. is a global healthcare company committed to innovative therapies. We design, develop, manufacture, and market novel products addressing significant medical challenges. Our products are sold primarily through a direct sales organization in the United States, Europe, Canada, and Australia, alongside distributors in select international markets.

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 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.