- Title: Reliability Engineer
- Code: RCI-18504
- Location: North Chicago, IL 60064
- Posted Date: 06/27/2022
- Duration: 12 Months
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- Name:Sagar Shah
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 233
Job Position Description and Requirements:
- Client is one of global top 10 pharmaceutical companies located in North Chicago.
- Client 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
- Reliability and safety is proactively designed into our products
- Potential risks are analyzed and controlled, and
- Product/system performance is quantifiably predicted. This contract job is a one-year contact and open for extension based on project progress. The assignment is 40 hours per week and working facility in North Chicago.
- 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.
- 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.