Systems Engineer-Hybrid

ELYON International; New Kensington (Westmoreland County); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid sick leave

401(k) Retirement Plan

Employer Paid Life Insurance

Employer Paid Short Term Disability

Job summary

ELYON International, Inc. in Pennsylvania seeks a Senior Reliability Engineer to drive reliability plans and analyses for new products within Sleep & Respiratory Care.

You will lead quality initiatives, oversee Weibull and hazard analyses, and coordinate FMEAs, ensuring robustness across design and manufacturing processes. You’ll collaborate with product engineering, suppliers, and manufacturing, while navigating medical device regulatory requirements (ISO 13485, IEC 62304, 14971) and driving

Qualifications

• B.S. in a technical field; Masters preferred.
• Electrical and software development experience preferred.
• Regulatory knowledge including ISO 13485, IEC 62304, 14971; MDSAP exposure.

Responsibilities

• Develop reliability requirements and reliability plan for new products.
• Lead quality efforts to reduce warranty and improve customer satisfaction.
• Conduct reliability testing and analyses (Weibull, hazard, regression).
• Perform DesignFMEA and recommend design changes.
• Collaborate with manufacturing on new technologies and processes.
• Provide technical feedback to enhance product quality.
• Support training on reliability, robustness, and statistics.

Skills

Electrical

Mechanical

Bioengineering

Software Engineering

Reliability

Quality engineering

Medical device knowledge

Regulatory understanding

Education

B.S. in a technical field

Masters degree preferred

Job description

• 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 DesignFMEAs 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.
• Certified Reliability Engineer - Preferred
• Six Sigma GB/BB - Preferred

• HYBRID** 3 days in office

Local to PA

You are responsible for

• 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 DesignFMEAs 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.
• Certified Reliability Engineer - Preferred
• Six Sigma GB/BB - Preferred

You are part of

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 and the following

• B.S. in a technical field, Electrical, Mechanical, Bioengineering, Software Engineering etc. Masters degree preferred.
• Electrical and software development experience is preferred
• Material science or plastics engineering experience is preferred
• Expertise with Design Quality, Reliability and Safety/Compliance is a must.
• ASQ certifications (CQE, CRE, CMQ/OE etc) Preferred.
• 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
• Certified Reliability Engineer - Preferred
• Six Sigma GB/BB - Preferred
• 4+ years of experience in design quality, quality engineering, or reliability

Benefits

Paid sick leave, Medical/Dental (optional), 401 (k) Retirement Plan (optional), Employer Paid Life Insurance, Employer Paid Short Term Disability, Optional Life Insurance.

ELYON International, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.