Product Quality Hardware Engineer

Product Quality Hardware Engineer

Location:

Mountain View, California, USA Travel:
Expected Travel is up to 20%

Minimum Qualifications:

• Bachelor's degree in Engineering or Science Related Field
• 5 years of experience in Medical Device Manufacturing
• Understanding 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 regulators
• Experience in Program Management, Training and working with hardware development teams
• Experience with Medical Device Product Development Lifecycle
• Familiarity with ISO
  13485 and 21 CFR Part 820 and Quality Management Systems (QMS)
• Excellent organizational, independent productivity, and verbal and written communication skills
• Ability to travel internationally up to 20%

Preferred Qualifications:

• Masters Degree in Engineering or Science Related Field
• Certified Quality Engineer (ASQ) or Six Sigma Green/Blackbelt
• Experience with both Consumer and Regulated Products
• Experience working with Client technologies in an ambiguous and innovative environment
• Experience with Risk Management, Design/Process Verification and Validation
• Strong knowledge of Quality Concepts (Statistical Analysis, NC/CAPA, Audits)
• Experience with Good Documentation Practices and Good Manufacturing Practices
• Applied knowledge of Quality tools such as Failure Modes Effect Analysis (xFMEA), Root Cause Analysis, and Mistake Proofing/Poke Yoke