Research and Development Engineer

hace 2 semanas


Valencia, Estado Carabobo, Venezuela Cynet Systems A tiempo completo
Responsibilities:Build Quality into all aspects of their work by maintaining compliance with all quality requirements.Ensure all Design Controls aspects of an acquisition are remediated.Develop new requirements, source new requirements, create and validate new test methods, create new risk documentation, and perform all applicable testing.Support manufacturing moves from one vendor to another.Support project work for EUMDR approval.Maintain product safety, quality, and compliance of all products.Be trained in all aspects of change management (DCA, SCIA, SCAR, and PLCP).Support any applicable R&D project planning and activities.Understand and comply with all the regulations governing the quality system.Support additional activities required by the business.Minimum Requirements:2+ years working with design controls.2+ years of project leader/manager experience.2+ years working within FDA Quality System Regulations and ISO 13485.Experience with assessing quality and compliance impact on products for design and process changes.Experience with design verification and validation activities.Experience with Test Method development.Experience in troubleshooting and root cause analysis.Self-motivated individual who can work independently.Working knowledge of MiniTab and SolidWorks.Good writing (assessments, protocols, reports, and email) and verbal communication skills.Qualifications:5 - 8 Years with BS, 3 - 6 Years with MS, 0 - 3 Years with PhD.Has led 4+ projects to drive product design changes or process changes preferred.3+ years of Electro/Mechanical experience.Has participated in 4+ new product development projects, related product transfer, and scale-up activities preferred.Knowledge of manufacturing processes including silicone molding, laser welding, resistance welding, small part assembly, cleanroom operations, vision inspection systems, soldering, electronic component assembly, electrical testing, and packaging.SAP and Windchill experience is a plus.Human Factors/Usability experience is a plus.
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