Provide quality assurance leadership and support for mechanical product development, design change efforts, and manufacturing through participation on project teams. Perform the following types of tasks as needed, ensuring compliance with industry standards and regulatory requirements:
Support design verification and validation efforts through review of plans, review of design verification and validation protocols and reports
Support component and process verification and validation, design and technical reviews
Participate in risk management activities and assist in the management and maintenance of risk management documentation, such as process and design FMECAs, FTAs, risk analyses, etc.
Participate in design for manufacturability analyses, reviews, and design transfer activities
Support manufacturing cost reductions, yield improvements, and MRB failure analysis activities including process changes, tooling, and equipment.
Provide quality oversight of suppliers by auditing suppliers, working with Development and Materials on supplier selection, evaluating supplier changes, communicating with suppliers on development of and qualification of new components/processes, and addressing performance issues as needed to ensure successful business relationships.
Participate as a member of the engineering change board, ensuring that released parts and documents are accurate and complete; and ensuring that supporting documentation is adequate.
Collect and analyze Quality Management System data as assigned and present results to management.
BS degree in a recognized engineering discipline, preferably Mechanical Engineering
5 years minimum experience as a quality professional, preferably in a medical device or related industry
Familiarity with FDA Quality System Regulations and ISO 13485:2003/2016 highly desirable. Familiarity with ISO 9001:2015, QS-9000, and knowledge of ISO safety standards is a plus.
Experience in product manufacturing & development, project management, and supplier auditing/management highly desired
Excellent interpersonal skills, both written and verbal, are essential.
Additional Salary Information: We provide a comprehensive compensation program including salary, benefits and pre-IPO stock options
About NeuroPace Inc.
The RNS® System is an award-winning technology developed and manufactured in Silicon Valley that has been recognized for its innovation. Similar to a pacemaker that monitors and responds to heart rhythms, the RNS System is the world’s first and only medical device that can monitor and respond to brain activity.
NeuroPace was founded to design, develop, manufacture and market implantable devices for the treatment of neurological disorders with responsive stimulation. The company’s initial focus is the treatment of epilepsy, a debilitating neurological disorder affecting approximately 1% of the population worldwide.
In addition to treating epilepsy, responsive neurostimulation holds the promise of treating several other disabling medical disorders that impact the quality of life for millions of patients around the world.
Located in Mountain View, California, NeuroPace is a privately-held company with approximately 150 employees
We offer comprehensive compensation plans including: salary, benefits and pre-IPO stock options.
In this episode, I talk to about the difference between big picture thinking versus a detailed orientated mindset and how to benefit from both in your engineering career. I will detail the benefits of each of these thinking patterns and provide strategies for utilizing both effectively as a technical professional. Engineering Quotes: Here are some […]