Sr Engineer, Quality

Job Summary

The Quality Engineer position at Masimo is a multifaceted role that requires a wide breadth of engineering knowledge. An individual in this role will work as part of the Product Assurance department to help drive quality in the company's growing product portfolio. As an integral part of the product development team, quality engineers help guide and direct the team to produce quality products. As a result, a person in this position should be comfortable in all facets of quality engineering through all stages of a typical product lifecycle (Design, Verification and Validation Testing, Production, and Post-Market). A successful person in this role will exhibit the following: Excellence in working in a team environment, Strong engineering knowledge, Good understanding of quality engineering, Commitment to a career in quality, Ability to take on and overcome challenges, and have a general interest in improving products and processes.

Duties & Responsibilities

• Support the Product Assurance goal of driving making quality a competitive advantage;
• Maintain up to date knowledge of Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR), MDD 93/42 EEC and other applicable international medical device standards and regulations;
• Participate in problem solving activities related to design, manufacture, inspection, and test, including CAPA, NCR and supplier related issues;
• Solve identified issues through analysis, critical thought, and development of a clear set of recommendations to the team and management for resolution;
• Participates in in the improvement of product and manufacturing quality and reliability through tools appropriate for the project, such as test sample size selection, test method validations, Gage R&R studies, and SPC.
• Contribute as part of multi-departmental teams in product and process risk analysis and risk management activities, including the development of product and process FEMA and Risk Analysis reports.
• Ensures robust application of the quality system by supporting the entire Quality Management System including the CAPA, NCR, customer feedback activities, and product failure analysis;
• Develop and maintain Design History Files (DHF) for products;
• Perform other duties or special projects as requested.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• 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;

Preferred Qualifications

• Certified Quality Engineer (CQE)
• Experience with sterilization validations
  

Education

• B.S. in Electrical Engineering, Biomedical/Biomechanical Engineering, or a related science/engineering discipline is required.
• M.S. in a related Engineering or science discipline is a plus.

Compensation: The anticipated range for this position is $80,000 - $130,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.