Contract Length: 12 months

Location: North Chicago, IL

Pay Rate: $32-42/hr based on experience

Reliability Engineer

Combination Products team of the Operations Science and Technology has an opening for a Reliability Engineer with the focus on drug-device delivery systems to support pipeline and on-market products. As a Reliability Engineer, you will support new product development and continuous improvements of commercial medical devices. You will engage in the project teams with responsibility for technical assessments and compliance activities to ensure that:

1. Reliability and safety is proactively designed into our products
2. Potential risks are analyzed and controlled, and
3. Product/system performance is quantifiably predicted.

Job Requirements:

• Preferred MS degree with 0-3 years of reliability engineer, mechanical, electric engineering or relevant filed or BS degree in technical or scientific discipline with 0-6 years. Recent graduate with Ph.D. degree will be considered.
• Excellent skills of qualitative assessment and quantitative analysis from general product risks down to specific failure modes.
• Contribute to the overall system-based reliability architecture approach using analytical reliability tradeoffs among early concepts.
• Solid team player working in matrix team with strong scientific knowledge in medical devices and/or drug-device delivery systems.
• Serve as a trusted technical expert of high-reliability, safety-critical systems from concept phase to mass production.
• Ability to solve complex multidisciplinary problems with high quality results on schedule.
• Experience product systems that are resilient of HALT and HASS to accelerated stress/temperature environments, mechanical vibration, environmental stress analysis, electrostatic discharge (ESD), and/or high electrical and friction noises.
• Root cause analysis and solve difficult technical problems of drug-device delivery system and combination products.

Preferred Experiences:

• Experience in demonstrated success in applied electro-mechanical engineering with a reliability focus.
• Experience in design for reliability at medical products from system-level reliability and component level reliability.
• Experience in reliability analysis of both durable pumps and automatic assembly of high-volume disposable medical products.
• Experience in developing and conducting reliability models to predict device delivery product failure rates and patient complaint rates.
• Experience in engaging and working in matrix teams through product development processes and failure mode and root cause analysis of complex problems.
• Experience in new product launches, sustaining products once on market, defining problem statement and solving complex problems.
• Experience in working in GLP/GMP at matrix structures cross functional teams and organization.
• Familiarity with risk analysis methodologies of failure mode and effects analysis (FMEA) and failure modes, effects and criticality analysis (FMECA) toward reliability prioritized engineering actions.
• Able to apply physics-of-failure to develop lifetime usage and use-stress probability models to estimate product failure rates and patient complaint rates.
• Able to develop reliability test plans and protocols for reliability testing of the select design, materials or processes; capable of statistical strength models of durable pump specific failures, and reliability demonstration.
• Familiarity with engineering standards, FDA regulation, performance confirmation methods and development practices of new product development and continuous improvements.
• Able to develops/executes highly accelerated life test (HALT), highly accelerated stress screening (HASS), environmental, transportation, life testing, PCBA stress screening, engineering tests and/or V&V to ensure timely and efficacious completion of development projects within budgetary and resource constraints
• Familiarity with ITEM, MATLAB, LabVIEW, Python, JMP, Mote Carlos and Tableau and other computer software skills.
• Mathworks - Simulink - Simscape software for system modeling analysis and reliability analysis.

Candidates

• Preferred MS with medical device / device drug delivery systems related reliability working experiences or newly graduated Ph.D. in reliability field