Product Quality Hardware EngineerLocation: Mountain View, California, USA Travel: Expected Travel is up to 20%Minimum Qualifications:Bachelor's degree in Engineering or Science Related Field5 years of experience in Medical Device ManufacturingUnderstanding of US and International Medical Device Regulations with experience interacting with Regulatory Agencies (FDA, Notified Bodies, etc)Experience participating in regulatory and quality audits and presenting technical subjects to regulatorsExperience in Program Management, Training and working with hardware development teamsExperience with Medical Device Product Development LifecycleFamiliarity with ISO13485 and 21 CFR Part 820 and Quality Management Systems (QMS)Excellent organizational, independent productivity, and verbal and written communication skillsAbility to travel internationally up to 20%Preferred Qualifications:Masters Degree in Engineering or Science Related FieldCertified Quality Engineer (ASQ) or Six Sigma Green/BlackbeltExperience with both Consumer and Regulated ProductsExperience working with Client technologies in an ambiguous and innovative environmentExperience with Risk Management, Design/Process Verification and ValidationStrong knowledge of Quality Concepts (Statistical Analysis, NC/CAPA, Audits)Experience with Good Documentation Practices and Good Manufacturing PracticesApplied knowledge of Quality tools such as Failure Modes Effect Analysis (xFMEA), Root Cause Analysis, and Mistake Proofing/Poke Yoke