Highlights
Apply advanced reliability engineering tools and methodologies such as Weibull analysis, Reliability Modeling, Fault Tree Analysis, Accelerated Life Testing (ALT), HALT/HASS, and structured root cause analysis to drive data-based design decisions. As a Staff Reliability Quality Engineer to ensure product reliability and quality within a complex medical device product through the development and execution of product reliability test plan by way of verification procedure based upon product and design specifications.
Numbers & Facts
| Location | San Jose, CA |
| Industry | Computer Software |
| Company Size | 20 to 49 employees |
| Year Founded | 2014 |
| Website | http://www.tekfortune.com/ |
Description
Tekfortune is a fast-growing consulting firm specialized in permanent, contract & project-based staffing services for world s leading organizations in a broad range of industries. In this quickly changing economic landscape, virtual recruiting and remote work are critical for the future of work. To support the active project demands and skills gaps, our staffing experts can help you find the best job for you.
Job title: Staff Reliability Engineer
Location: San Jose, CA (Onsite 5 days in a week)
Fulltime / Direct Hire
Keywords: Accelerated Life testing (ALT or HALT), Weibull Analysis, Bath-tub curve prediction, RAMS (Reliability & Maintenance), ReliaSoft or Relyence Software exposure.
Job Description:
As a Staff Reliability Quality Engineer to ensure product reliability and quality within a complex medical device product through the development and execution of product reliability test plan by way of verification procedure based upon product and design specifications. This role will partner closely with R&D, Systems Engineering, Manufacturing, and Quality teams to ensure highly reliable robotic medical systems are designed, verified, and launched successfully.
What Your Day-To-Day Will Involve:
The Qualifications We Need You to Possess
The Qualifications We Would Like You to Possess
For more information and other jobs available please contact our recruitment team at
Job title: Staff Reliability Engineer
Location: San Jose, CA (Onsite 5 days in a week)
Fulltime / Direct Hire
Keywords: Accelerated Life testing (ALT or HALT), Weibull Analysis, Bath-tub curve prediction, RAMS (Reliability & Maintenance), ReliaSoft or Relyence Software exposure.
Job Description:
As a Staff Reliability Quality Engineer to ensure product reliability and quality within a complex medical device product through the development and execution of product reliability test plan by way of verification procedure based upon product and design specifications. This role will partner closely with R&D, Systems Engineering, Manufacturing, and Quality teams to ensure highly reliable robotic medical systems are designed, verified, and launched successfully.
What Your Day-To-Day Will Involve:
- Lead system-level reliability strategy and testing for complex electromechanical medical devices, ensuring robust product performance across the design lifecycle
- Apply advanced reliability engineering tools and methodologies such as Weibull analysis, Reliability Modeling, Fault Tree Analysis, Accelerated Life Testing (ALT), HALT/HASS, and structured root cause analysis to drive data-based design decisions
- Define reliability requirements, reliability growth plans, and reliability demonstration strategies for NPI programs and sustaining design changes ; devise test protocols and write test reports
- Design and execute reliability test protocols for mechanical, electrical, environmental, and software-driven subsystems across system, subsystem, and component levels.
- Partner with Systems Engineering and R&D to ensure proper linkage between design requirements, risk management, reliability verification, and validation activities.
- Drive reliability insights through analysis of field data, complaint trends, and nonconformance data to support product improvements and risk mitigation.
- Collaborate cross-functionally with R&D, Manufacturing Engineering, Supplier Quality, Regulatory Affairs, and Failure Analysis teams to resolve reliability issues and improve product robustness
- Develop and implement reliability testing infrastructure, including custom fixtures and automated test setups
- Champion a data-driven reliability culture by mentoring engineers and promoting best practices in reliability engineering and statistical analysis
- Ensure compliance with ISO 13485, FDA Quality System Regulations (21 CFR 820), and applicable regulatory standards
- Understand and adhere to the PROCEPT BioRobotics EHS policy
The Qualifications We Need You to Possess
- Bachelor s or Master s degree in engineering (e.g. Biomedical/Electrical/Mechanical)
- 5+ years of experience working in medical device or equivalent regulated industry demonstrative of Reliability expertise.
- Background in Capital Equipment and/or complex electromechanical and embedded software devices.
- Experience defining and executing Accelerated Life Testing (ALT), HALT/HASS, and reliability verification strategies.
- Perform reliability prediction analyses using established industry standards such as MIL-HDBK-217, Telcordia, and FIDES.
- Maintain automated testing frameworks using Python and C++ to perform testing.
- Strong analytical, problem-solving, statistical analysis and communication skills with the ability to influence cross-functional engineering teams.
The Qualifications We Would Like You to Possess
- ASQ CQE, or CRE certification preferred
- Basic machine tool and manufacturing experience a plus
- Experience with medical device testing or development a plus.
For more information and other jobs available please contact our recruitment team at
careers@tekfortune.com
. To view all the jobs available in the USA and Asia please visit our website at https://www.tekfortune.com/careers/ .About Company
Tekfortune is a software solutions company providing project development and staff augmentation services to companies in various industries including Healthcare, Banking, Finance, Telecommunication and Aviation.
Tekfortune Inc delivers solutions to a wide variety of organizations of various sizes and industries. Our clients include mid-market to Fortune 1000 companies spanning across industries such as: Insurance, Financial, Pharmaceutical, Manufacturing, Retail and many others.
In Tekfortune Inc, we are offering selection of services and solutions at very reasonable rates. With years of experience in the placement and recruitment Industry and over time we have acquired the knowledge essential to comprehend the exact need and dependence on customers. Therefore we provide the customers the best and also the brightest candidates for vacancies. Moreover, by understanding the working interest of customers who is able to place them within the companies where they are able to get maximum opportunity for professional growth.
Tekfortune Inc has a strong emphasis on quality. Its goal would be to achieve client satisfaction by looking into making deliveries satisfaction of customer's business needs. Our ability to quickly identify and effectively employ proven fundamental principles, techniques and resources yields highly desirable results for our clients.
We understand that each industry and organization share a level of uniqueness that requires a tailored approach in order to deliver specific solutions. Such factors as client culture, industry regulations, organizational maturity, financial health and many more items may impact our approach to delivering client solutions.
Having served a wide variety of clients has provided Tekfortune the ability to build subject matter expertise across numerous industries. Our industry expertise combined with our specialized knowledge of Business Process Improvement, Requirements Management and Program & Project Management provides a powerful combination and a tremendous value to our clients.
We are run by a group of industry experts who have decades of experience in delivering custom solutions to our clients.
Tekfortune Inc delivers solutions to a wide variety of organizations of various sizes and industries. Our clients include mid-market to Fortune 1000 companies spanning across industries such as: Insurance, Financial, Pharmaceutical, Manufacturing, Retail and many others.
In Tekfortune Inc, we are offering selection of services and solutions at very reasonable rates. With years of experience in the placement and recruitment Industry and over time we have acquired the knowledge essential to comprehend the exact need and dependence on customers. Therefore we provide the customers the best and also the brightest candidates for vacancies. Moreover, by understanding the working interest of customers who is able to place them within the companies where they are able to get maximum opportunity for professional growth.
Tekfortune Inc has a strong emphasis on quality. Its goal would be to achieve client satisfaction by looking into making deliveries satisfaction of customer's business needs. Our ability to quickly identify and effectively employ proven fundamental principles, techniques and resources yields highly desirable results for our clients.
We understand that each industry and organization share a level of uniqueness that requires a tailored approach in order to deliver specific solutions. Such factors as client culture, industry regulations, organizational maturity, financial health and many more items may impact our approach to delivering client solutions.
Having served a wide variety of clients has provided Tekfortune the ability to build subject matter expertise across numerous industries. Our industry expertise combined with our specialized knowledge of Business Process Improvement, Requirements Management and Program & Project Management provides a powerful combination and a tremendous value to our clients.
We are run by a group of industry experts who have decades of experience in delivering custom solutions to our clients.
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