System Engineer-Medical Devices
2 weeks ago
Key Skills
Systems engineering medical device development system integration risk management ISO 13485 and FDA 21 CFR Part 820.
Responsibilities
Lead systems engineering efforts for medical device development from concept to commercialization.
Develop and manage system requirements architecture and design documentation.
Oversee hardware software and assay component integration into cohesive systems.
Conduct design reviews risk assessments and ensure compliance with regulatory standards.
Provide technical leadership and mentorship to junior engineers.
Requirements Bachelor s/Master s in Systems Engineering Biomedical Engineering Electrical Engineering or related field.
812 years of experience in systems engineering with 3 years in medical device development.
Strong understanding of design control risk management and regulatory standards.
Proven experience with system integration and troubleshooting complex electromechanical systems.
Excellent project management leadership and communication skills.
BenefitsAbout the Customer
You will be working with a trusted global product engineering and lifecycle services partner to the world s most recognized companies in the Aero Engines Aerospace & Defense HiTech Transportation (Auto and Rail) Power and Industrial Oil & Gas and Medical Devices industries. With 12K experts and a global presence in 73 locations across 15 countries it believes that it is at the forefront of the convergence of mechanical electronics software and digital engineering innovations to enable solutions for a safer cleaner world. A Strong Process based organization Certified for CMMI L5 and multiple other certifications of the process and one of the few organizations which are ranked as best place to work.
Systems engineering, medical device development, system integration, risk management, ISO 13485 and FDA 21 CFR Part 820.
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