Senior Quality Engineer - Medical Devices

General Summary

Join us in supporting the production of life-saving medical devices! As a Senior Quality Engineer, you will play a pivotal role in ensuring high-quality manufacturing of Class II / III interventional devices. This position offers the chance to tackle advanced problems that require in-depth analysis and collaboration with cross-functional teams to implement effective quality solutions.

Specific Duties and Responsibilities

• Assist Commercial Operations and Manufacturing with Incoming / In-process / Final Inspections, NCRs, CAPAs, Engineering Change Orders, Control Chart Investigations, Deviation Authorizations, and equipment maintenance.
• Support and analyze manufacturing product lines, conducting failure analyses and defect investigations as needed.
• Drive Continuous Improvement initiatives across the organization.
• Manage supplier-related activities including Second Source Qualifications, Supplier Changes, and SCARs.
• Engage with engineering departments and suppliers regarding quality-related matters.
• Lead or assist in the creation and revision of manufacturing documentation.
• Design and optimize Test Methods, Testing Equipment, and Test Method Validations (TMVs).
• Recommend enhancements to specifications, acceptance criteria, and manufacturing documents to boost product quality and operational efficiency.
• Mentor junior Quality Engineers in support of departmental activities.
• Comply with the Quality Management System and carry out other duties as required.
• Ensure compliance with QMS, regulations, standards, and procedures among all team members.

Position Qualifications

Minimum Education and Experience :

Additional Qualifications :

Working Conditions

This role involves working in general office, laboratory, and cleanroom environments. The position may require lifting and moving items weighing up to 25 pounds. Frequent standing, walking, sitting, and computer use for extended periods are expected. Specific vision abilities include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

Located in Alameda, CA, the starting base salary ranges from $109,000 to $152,000 per year.

What We Offer

Be part of a collaborative team where continuous learning is emphasized, and achievements are recognized. Contribute to groundbreaking advancements in the treatment of critical health conditions. We also provide a comprehensive benefits package for eligible employees, including medical, dental, vision, life insurance, 401(k) with employer match, employee stock purchase plans, generous vacation and sick leave, and much more.

Penumbra, Inc., headquartered in Alameda, California, is dedicated to pioneering healthcare solutions. We design, develop, manufacture, and market innovative medical products aimed at addressing serious health challenges globally. Our offerings are primarily sold to hospitals and healthcare providers through a direct sales organization and select international distributors.

Qualified candidates will be considered for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any characteristic protected by laws.

If you are in California, please review Penumbra's Privacy Notice for California Residents.

For further details on our commitment to being an equal opportunity employer, see Penumbra's AAP Policy Statement.