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NeuroPace was founded to design, develop, manufacture and market implantable devices for the treatment of neurological disorders by responsive brain stimulation. The company's initial focus is the treatment of epilepsy, a debilitating neurological disorder affecting approximately 1% of the population worldwide. A clinical trial of the company's RNS® System for treating medically refractory epilepsy is ongoing, but not enrolling new participants.

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 90 employees.

Job Description:
Outstanding job opportunity for a Mechanical Quality Engineer.  Originally this position will be a generalist focused on all quality engineering functions as related to mechanical development.  As the Company moves toward commercialization, this position will become focused as either a Supplier Quality Engineer or a Manufacturing Quality Engineer based upon the candidates strengths and interest.

Responsibilities:
1. Provide quality engineering support for product development and design change efforts through participation on project teams.
• Participate in development of project schedules, plans, and DHF deliverables, including product requirements and risk management documentation; participate in design verification and validation activities
• Participate in manufacturing process development, manufacturability analyses and transfer to manufacturing, including process validation, tooling and equipment qualifications
2. Provide quality engineering support for manufacturing activities.
• Support new and ongoing manufacturing efforts and participate in process improvements, including manufacturing ramp up activities
• Assist with resolution of product and process defects focusing on root cause analysis, risk assessment and implementation of effective corrective action
3. Provide quality engineering support for supplier management.
• Support evaluation and selection of new suppliers; establish supplier performance metrics
• Develop relationships and work with suppliers on new development, part issues, corrections, changes, and improving supplier performance
• Perform audits of suppliers per schedule
4. Provide statistical analysis guidance in all areas of the quality system
5. Participate on change control board for design and manufacturing changes
6. Perform trending of key quality system elements and prepare data for management reviews
7. Based on interests of candidate, this position is expected to transition to a Manufacturing Quality Engineer or Supplier Quality Engineer position to support commercialization efforts

Requirements:
1. Minimum of BS degree in Mechanical Engineering; additional BS degree in Materials a plus.
2. Minimum 1-3 years experience in a development or manufacturing environment; 2-5 years medical device or automotive experience preferred
3. Familiarity with FDA Quality System Regulations and ISO 13485:2003 highly desirable.  Familiarity with ISO 9001:2008, QS-9000, and knowledge of ISO safety standards is a plus
4. Demonstrated attention to detail and excellent interpersonal skills, both written and verbal, are essential