Systems Engineer-Hybrid

Elyon International•New Kensington, PA

5d•Hybrid

About The Position

This position is within the Sleep & Respiratory Care Business Group, a business group of the company. We are highly dynamic, ambitious, and agile within a fast-changing industry. Our vision is to work together with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions. This position reports directly to the Head of Quality Engineering for SRC. To succeed in this role, you’ll need a customer-first attitude.

Requirements

B.S. in a technical field, Electrical, Mechanical, Bioengineering, Software Engineering etc.
Expertise with Design Quality, Reliability and Safety/Compliance is a must.
Strong understanding of medical device industry regulatory requirements including but not limited to MDSAP participating countries, ISO Standards (ISO 13485 and ISO 14971), EUMDR, IEC 62304, IEC 60601, IEC 62366.
Excellent organizational skills to lead and track deliverables
4+ years of experience in design quality, quality engineering, or reliability

Nice To Haves

Masters degree preferred.
Electrical and software development experience is preferred
Material science or plastics engineering experience is preferred
ASQ certifications (CQE, CRE, CMQ/OE etc) Preferred.
Certified Reliability Engineer - Preferred
Six Sigma GB/BB - Preferred

Responsibilities

Work with product engineering to develop reliability requirements, establish a reliability plan and perform appropriate analyses to ensure that new products meet all of the requirements.
Work with the project teams to develop a reliability plan to document tasks, methods, tools, tests and analyses that are required for the success of new products.
Assist engineering teams to achieve warranty reduction and improve customer satisfaction by leading quality efforts on problem identification, failure root cause analysis, corrective action development and resolution verification.
May participate and/or conduct training and workshops on quality and reliability engineering, robustness, and statistics as necessary within product engineering.
Participate in product design and reliability reviews during new product development to ensure robustness of product design and manufacturing processes.
Perform statistical data analysis, regression modeling, Weibull Analysis, hazard analysis, reliability growth assessment and prediction, target setting, warranty trend analysis and spending forecast for new products.
Perform Design FMEAs on all new products and recommend design changes to improve product reliability.
Work with Manufacturing to evaluate and qualify new technology and new processes implemented in manufacturing.
Conduct reliability testing on new and existing products.
Highly Accelerated Life Testing and Highly Accelerated Stress Testing to identify product failure modes.
Validate and track product requirements through development.
Conduct accelerated life testing on both the component and system level to provide feedback on design life which can be used to evaluate failure and safety risks within the project.
Participate in preparing schedules and work estimates for all project assignments and activities.
Provide technical feedback to enhance the on-going quality of products and services.
Effectively meet the needs of internal and external customers.
Ability to function effectively within a dynamic team environment.
Demonstrate ability to cope with stress and maintain a pleasant and cooperative temperament with internal and external stakeholders.
Demonstrate ability to perform mental tasks such as making decisions, learning, thinking rationally and exercising good judgment.