Reliability Engineer and Lab Coordinator

Siemens Healthineers

7d•Onsite

About The Position

This role is well suited to an ambitious professional who can work with minimal supervision. As a Reliability Engineer and Lab Coordinator, you will be responsible for the overall reliability modeling, testing and post-launch monitoring of our products. You will have an understanding of all aspects of Siemens Healthineers blood gas IVD point of care devices from design to manufacturing to field behaviors. You will use your knowledge of design for reliability to support product testing procedures or supporting/executing field performance studies. You will also be responsible for maintaining Reliability Lab equipment.

Requirements

Bachelor’s degree (Advanced degree preferred) in Mechanical /Biomechanical /Reliability Engineering or related discipline.
3+ years reliability engineering experience in highly regulated industry preferably in a medical device industry – 1+ years with a master’s degree.
Experience planning tests (DoE, sample size selection, etc.)
Experience in Reliability and statistical analysis software like Reliasoft/XFRACAS/Minitab.

Nice To Haves

Familiarity with design for reliability and reliability engineering.
Working knowledge of regulations and best practices for medical device development such as ISO 13485.
Ability to generate data and perform life data analysis.
Ability to manage multiple projects and prioritize tasks effectively.
Ability to communicate effectively with other engineers, managers, and stakeholders.
Demonstrated ability to lead, motivate, and collaborate with technical teams and drive results.
Ability to identify and solve complex problems related to design for reliability.
Ability to analyze data and identify patterns to develop solutions for potential problems.
Strong understanding of engineering principles and familiarity with relevant software and tools such as XFRACAS and ReliaSoft.
Ability to develop process and methodology to model system and subsystem reliability.
Ability to work with development teams to drive effective FMEA's and risk reduction.

Responsibilities

Working with R&D, quality assurance and manufacturing teams to develop reliability requirements (including requirements cascade), develop and implement comprehensive reliability test plans for IVD medical devices that align with product development and production processes.
Developing reliability plans and requirements, leading and facilitating Design Failure Mode and Effects Analysis (DFMEA).
Designing and developing test methods and fixtures to assess the performance and durability of IVD devices.
Writing test protocols, training personnel on test procedure, analyzing data and creating final reports.
Conducting reliability tests and documenting results, including environmental, lifecycle, and accelerated aging tests, to evaluate product performance under different conditions and in compliance with relevant regulatory standards and guidelines.
Analyzing test results and providing detailed reports, identifying areas for improvement and potential risks.
Leading and directing multiple projects in a fast-paced, cross-functional environment.
Participating in design reviews and working with engineering to drive DFR (Design for Reliability) process and tools and support in defining and executing reliability plans.
Reviewing device failures, performing root cause investigations, and documenting results in a failure reporting, analysis, and corrective action (FRACAS) system.
Compiling and analyzing performance reports and process control statistics; investigating and analyzing relevant variables potentially affecting product and processes.
Coordinating activities and equipment in the Reliability lab.