Candidates should possess an Associate’s or Bachelor’s degree in Engineering, a Life Science, or a related field, and have at least 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry environment, or an equivalent combination of education and experience. Familiarity with QSR, ISO, and other applicable regulations and laws is required, along with experience with Electronic devices and or PCBAs, and excellent verbal, written, and interpersonal communication skills.
The Quality Engineer II will develop and implement quality system elements to ensure the high-quality level of new and existing products as well as their compliance with applicable regulations and standards. They will collaborate in the development and qualification activities for new and existing products, develop testing and inspection methodology and documentation, collaborate on Quality Objective teams, design and install QC process sampling systems, perform failure analyses and defect investigations, analyze production limitations and standards, recommend revision of specifications, interface with engineering departments, customers, and suppliers on quality related issues, collaborate in the development of standard operating procedures, facilitate and perform internal audits, and ensure other members of the department follow the QMS, regulations, standards, and procedures. They will also understand relevant security, privacy, and compliance principles and adhere to applicable regulations, standards, and procedures.
Develops medical devices for vascular conditions
Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products, such as the Penumbra System and the Indigo System, are designed for use in hospitals and clinics, helping healthcare professionals address issues like stroke and other vascular diseases. These devices work by providing advanced tools for interventions in neurology and vascular surgery, allowing for effective treatment options. Unlike many competitors, Penumbra focuses specifically on these specialized areas, ensuring their products are tailored to the needs of medical professionals in these fields. The company's goal is to continuously improve and innovate their medical devices to enhance patient care and support healthcare providers in delivering effective treatments.