Masimo · 1 month ago
Engineer II, Product Assurance & Reliability
Irvine, CA, United States
Full-time
Onsite
Mid Level
$85K/yr - $100K/yr
3+ years expMasimo is a company focused on medical technology, and they are seeking a Product Assurance and Reliability Engineer II to enhance the quality and reliability of their product portfolio. The role involves investigating and testing products, providing expertise in microelectronics, and contributing to all stages of the product lifecycle.
BiotechnologyHealth CareManufacturingMedical Device
Responsibilities
Contribute to new medical microelectronics technology design, process, and material decisions through the development of quality and reliability risk assessments leveraging historical data, analytical modelling capabilities, and fundamental technical knowledge
Provide statistical analysis of quality and reliability data collected from assembled products and/or test vehicles for the prediction of product field reliability performance
Providing technical inputs on the design of medical microelectronics assembly test vehicles and semiconductor test devices
Designing and executing experiments to identify new failure mechanisms, determine fundamental technology envelopes, and define root cause solutions
Development and execution of efficient, robust, and salient technology certification strategies and plans
Clear communication of results, their impact, associated risks, and recommendations within the quality and reliability community and with partner organizations
Supporting early stage pilot production as part of technology transfer to high volume factories
Performing failure analysis using x-ray, DSC, SEM, and other analytical equipment
Implement HALT, HAST, JEDEC testing protocols
Support pilot manufacturing line(s) by performing quality/product assurance reviews and/or root cause analysis
Contribute to the development, implementation, and maintenance of SPC and other statistical techniques to ensure manufacturing remains in control
Assist identifying metrics and test methods improving the control of manufacturing processes and/or product reliability
Maintain skills and abilities in product assurance and reliability engineering relevant to industry practices
Qualification
Required
3 years' Product Assurance and Reliability Engineering experience or equivalent
2 years' experience in medical device design, development, and process development or equivalent
Demonstrable ability to apply JEDEC, IPC, and other industry standards toward the characterization of the reliability performance of semiconductor devices, components, and/or medical microelectronic assemblies
Experience in medical microelectronic device assembly, board-level process technology, and/or semiconductor fabrication processes
Experience in empirical data collection and statistical data analysis, reliability statistics, and design of experiments
Experience with the testing and analyzing of different materials and adhesives properties
Statistical analysis of quality and reliability data extracted from products and assembly test vehicles to predict field reliability performance
Preferred
Experience working with 21CFR820, ISO 13485 and 14971 requirements
Familiarity with a range of imaging and analytical lab test equipment such as x-ray imaging, SEM/EDX, acoustic microscopy, thermal analysis (DSC, TGA, DMA), chemical analysis (FTIR/ATR, GC-MS, GPC/HPLC)
Capable of organizing and performing engineering/scientific data analysis
Experience with statistical software JMP, MiniTab, Design Expert or equivalent
Experience with plastic molding processes
Demonstrated strength in technical and analytical problem solving
Require minimal guidance in daily activities
Demonstrate the ability to seek opportunities to improve product quality and reliability
Ability to clearly communicate
Ability to work in a team setting with people from a wide range of backgrounds
Be a positive and influential participant in a cross-functional environment
Benefits
Medical
Dental
Vision
Life/AD&D
Disability Insurance
401(k)
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
Cafe
Company
Masimo
Masimo Corporation, a medical technology company, develops, manufactures, and markets noninvasive patient monitoring products.
1001-5000 employees
H1B Sponsorship
Masimo has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (22)
2023 (27)
2022 (25)
2021 (24)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$754.95MKey Investors
Politan Capital ManagementRobecoBill & Melinda Gates Foundation
2022-08-15Post Ipo Equity· $750M
2017-08-26Post Ipo Equity
2016-11-11Grant· $4.95M
Leadership Team
Michelle Brennan
Board Chair
Recent News
Company data provided by crunchbase