[ENGINEERING] Senior Quality and Reliability Engineer
Position Location: CA, Headquarters - Irvine
Job Code Posting: 2241
Description
Masimo (NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning international medical technology and device company with operations spanning the globe. We develop innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. These revolutionary technologies are helping to solve "unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort out of blood monitoring. For more than 20 years, innovation has been and will continue to be our passion.
To learn more about us, please visit: www.masimo.com
Job Summary
The Senior Quality and Reliability Engineer (QRE) is expected to be the Masimo subject matter expert for product quality and reliability engineering and improvement. Masimo is a highly vertically integrated company that designs and manufactures complex electronic medical devices. Therefore, the engineer in this role will be immersed in Masimo product design and development, manufacturing methods, and monitoring and improvement of quality/reliability performance of fielded Masimo products. The Sr. QRE is expected to be highly self-motivated and demonstrate a driven desire to seek every opportunity to make Masimo product quality and reliability a competitive advantage.
The Senior Quality and Reliability Engineer is responsible for providing technical product quality and reliability leadership for all aspects of engineering throughout the product realization process, from product inception, development, and manufacture, to monitoring field performance. The Engineer has a key role with ensuring product meets defined quality and reliability standards. This position provides guidance to Engineering for Design for Reliability, contributes reliability engineering services when requested, calculates design Mean Time Between Failures (MTBF) based on current industry best practices, monitors fielded reliability return rates, recommends methods for improving short-term quality and long-term reliability, and supports all corporate product development activities including design control activities, process validations, and inspection and test activities.
Duties & Responsibilities
* Ensure that the Company’s quality system with respect to all aspects of product quality and reliability is implemented and maintained;
* Evaluate the electrical and mechanical reliability of product designs during the design and development stage;
* Develop reliability models, allocations and predications for the product system appropriate for complex electronic systems;
* Provide engineering with recommended design practice changes and product requirements for improved reliability based on scientific studies and analysis of fielded product complaints;
* Recommend and perform reliability testing for design reviews and final product release;
* Analyze repair and return data, and define opportunities for increased product manufacturing quality and product reliability;
* Evaluate current and future product testing for effectiveness and predictive value;
* Determine correlation between field failures and root cause, especially related to product design and validation and verification results;
* Develop, implement, and maintain SPC and other statistical techniques to ensure manufacturing remains in control;
* Identify manufacturing process control procedures that will increase product reliability;
* Initiate action to prevent the occurrence of any nonconformities relating to the product and process in manufacturing and in-service;
* Maintain skills and abilities in quality and reliability engineering relevant to industry practices;
* Perform other duties or special projects as requested.
Minimum Qualifications
* Five years of experience as an electronic product Reliability/Quality Assurance Engineer;
* Experienced in Quality System Regulations in ISO-13485/EN46001 or similar regulated environment;
* Experience in electronic systems reliability prediction methodologies and the use of predictive software tools;
* Demonstrated proficiency in statistical data analysis such as multivariate analysis, regression analysis, and Design of Experiments; Proven understanding of Continuous Improvement/Quality tools such as Design for Reliability, Design of Experiments, SPC, 6 Sigma, and FMEA/PFMEA;
* Proven competency in root cause analysis, life time prediction, and stress test correlation analysis;
* HALT/HASS development and implementation;
* Mechanical endurance and life testing related to PWBA and electronic systems;
* Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, manufacturing, sales and marketing, and administration;
* Good conceptual, analytical, problem solving, and organizational skills;
* A “hands-on” individual, who enjoys challenge, and is capable and dedicated to getting the job done with minimal support and direction;
* Capable of managing several simultaneous projects and tasks effectively in a dynamic, fast-paced environment;
* Well-organized and accustomed to maintaining excellent records;
* Ability to obtain and maintain a passport and travel to Mexico;
* Ability to lift up to 50 pounds;
Preferred Qualifications
* Certified Reliability Engineer;
* Six Sigma certification;
* Software reliability assurance experience;
Education
A Bachelor’s degree in Electrical Engineering is highly preferred.A Bachelor’s degree in Computer Science or other technical discipline and a proven proficiency in complex electronic products will be considered.A Master’s degree in a Science or Engineering discipline is a plus.
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. The ability to lift up to 50 pounds is required. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. Some travel to Mexico is also required, so the ability to obtain and maintain a valid passport 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.
We are proud to offer if eligible a highly competitive compensation plan with an excellent benefits package including three weeks vacation, stock options, 401k match, medical, dental, vision plans and much more!
Masimo is an Equal Employment Opportunity Commission / Affirmative Action employer, We encourage Minorities, Females, Disabled and Veterans to apply.
***NO AGENCIES PLEASE*** Thank you!