Quality Engineer I

Penumbrainc Inc.

Job Overview

Location

Alameda, CA

Job Type

Full-time

Full Job Description

📋 Description

• As a Quality Engineer I at Penumbrainc Inc., you will play a critical role in ensuring the safety, reliability, and regulatory compliance of life-saving medical devices used to treat complex vascular and neurovascular conditions. Your work directly impacts patient outcomes by upholding the highest quality standards from product design through manufacturing and post-market surveillance.
• You will apply technical expertise and creative problem-solving across the entire product lifecycle—supporting design control, driving process improvements, investigating quality issues, and ensuring adherence to stringent quality management systems (QMS) and global regulatory requirements.
• Day-to-day responsibilities include providing input into design control processes for new product development, independently applying knowledge of Penumbra’s QMS to sustain manufacturing operations and support supplier quality initiatives.
• You will identify and lead opportunities for process improvement, yield enhancement, and cycle time reduction, using data-driven approaches to optimize manufacturing efficiency without compromising quality.
• A core function of the role involves determining the root cause of in-process quality assurance issues through systematic investigation, applying tools such as 5 Whys, fishbone diagrams, and CAPA methodologies.
• You will leverage hands-on experience from production lines manufacturing high-performance medical devices to inform quality decisions and ensure real-world applicability of quality standards.
• Ensuring compliance with the company’s QMS as well as domestic (e.g., FDA 21 CFR Part 820) and international (e.g., ISO 13485) quality system regulations, standards, and procedures is a fundamental expectation.
• You will also mentor and guide other department members to follow QMS protocols, fostering a culture of quality ownership and accountability across teams.
• Additional duties may include performing audits, supporting documentation control, participating in design reviews, and contributing to continuous improvement initiatives using Lean or Six Sigma principles.
• The role operates in a dynamic, collaborative environment where navigating ambiguity is encouraged, and your contributions are valued in solving complex, technical quality challenges.
• You will work across general office, laboratory, and cleanroom settings, requiring adaptability and strict adherence to safety protocols, including potential exposure to biological hazards.
• Physical demands include occasional lifting of up to 25 pounds, mobility between buildings and floors, and prolonged periods of stationary work involving computer use, documentation, and data analysis.
• Strong written and verbal communication skills are essential for preparing reports, writing procedures, exchanging information with cross-functional teams, and interacting with personnel at all organizational levels.
• This position offers a unique opportunity to grow your expertise in medical device quality engineering within a mission-driven company that values innovation, technical rigor, and patient safety.
• You will gain deep exposure to regulatory frameworks, quality systems, and advanced manufacturing processes, positioning you for long-term career advancement in the healthcare technology industry.

🎯 Requirements

• Bachelor’s or Master’s degree in engineering, life sciences, or a related scientific discipline
• 1+ years of experience in a manufacturing, laboratory, or quality-focused environment
• Proven ability to thrive in a fast-paced, ambiguous work environment with strong problem-solving skills
• Clear and concise written and oral communication skills
• Familiarity with Quality Management Systems (QMS), GMP, ISO 13485, or FDA regulations (preferred)

🏖️ Benefits

• Competitive salary range of $72,000 to $94,000, based on experience and performance
• Opportunity to work on impactful medical devices that improve patient outcomes globally
• Collaborative, feedback-rich culture with access to mentorship and professional development
• Exposure to cutting-edge manufacturing environments including cleanrooms and laboratories
• Comprehensive benefits package (health, dental, vision, retirement) – standard for Penumbrainc Inc. roles

Skills & Technologies

Onsite

Degree Required

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Penumbrainc Inc.

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About Penumbrainc Inc.

Penumbrainc is a biotherapeutics company advancing precision-engineered antibodies that modulate the complement system to treat severe autoimmune and inflammatory diseases. Its lead programs target dysregulated complement activation underlying conditions such as paroxysmal nocturnal hemoglobinuria, cold agglutinin disease, and Guillain-Barré syndrome. The company applies structural biology insights to create long-acting, subcutaneous therapies with improved safety and dosing convenience over existing intravenous treatments. Founded in 2020 and headquartered in South San Francisco, Penumbrainc is advancing candidates through preclinical and early clinical development with the goal of delivering first-in-class complement inhibitors to patients with high unmet medical need.

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