Engineer II, Quality

Masimo is seeking a Quality Engineer to join their Product Assurance department. The role involves driving quality throughout the product lifecycle – Design, Verification, Validation, Production, and Post-Market. This position requires a commitment to product quality, strong engineering skills, and a team-oriented approach. Responsibilities include maintaining regulatory compliance, problem solving, and contributing to continuous improvement.

Requirements

• 3 years of Quality Engineering/Quality Assurance experience
• 2 years’ experience in a medical device design, development, and manufacturing environment
• Direct experience with ISO 13485 and FDA QSRs
• Direct experience in Test protocol development and execution in support of new product development and/or failure analysis
• Hands-on experience implementing and using statistical methods throughout various aspects of product realization, including use of PFMEA, DFMEA, DOE and GR&R methodologies
• Strong communication, documentation, problem solving and teamwork skills
• Ability to occasionally travel domestically and internationally
• Proficiency with Microsoft Office applications
• Prior experience with PLM, MMS, ERP systems

Benefits

• Medical
• Dental
• Vision
• Life/AD&D
• Disability Insurance
• Vacation
• Sick
• Holiday
• Paid Maternity Leave
• Flexible Spending Accounts
• Voluntary Accident
• Critical Illness
• Hospital
• Long-Term Care
• Employee Assistance Program
• Pet Insurance
• On-site wellness clinic, fitness center, and cafe