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Position Details: System Engineer-Process : ISO 13485

Location: Milpitas, CA
Openings: 2


Job Title System Engineer
Relevant Experience 
(in Yrs) 6+
Technical/Functional Skills  Working experience in system engineering field
Experience Required Understanding of ISO 13485, ISO 14971, IEC 60601, IEC 62366, FDA 21 CFR Part 820, and FDA human factors guidance
Basic knowledge of medical terms, anatomy, physiology, and procedures 
Minimum 5 years work related systems engineering experience required
Must have a solid base of understanding in mechanical, electrical, and software  
Roles & Responsibilities Able to interpret customer and marketing inputs to define technical design requirements.
Utilize QFD (quality, function, and deployment) and surgical procedure knowledge to define product and design options.
Develop appropriate test techniques to verify requirements.
Use FEA or other analysis tools to determine reasons for failure(s). Identify areas of concern within analysis.
Develop FMEA with assistance from the Design Team.
Analyze failure modes, risk associated with the failure mode, and develop appropriate factor of safety
Understand FDA human factors guidance and IEC 62366 standard.
Evaluate initial use case, foreseeable use errors, and hazards created by Industrial Designers.
Work with Industrial Designers in the development of the user interface.
Work on design elements (e.g., hardware/software and subsystem interface requirements, software requirements, risk mitigation, electrical and electro-mechanical safety, and user interface design)
Develop test plans for sub-assemblies and assemblies.
Review design documentation (e.g. DHF) of Intraocular Lens Delivery System, Phacoemulsification System, Femtosecond Laser System, Excimer laser System and remediate design documentation
Identification of gaps in user needs, product requirements and critical quality attributes (CQA)
Review risk management file to identify gaps in system risk assessment and accordingly remediate RMFs. If no system risk management file exists, develop system risk management document 
Generic Managerial Skills Must have strong organizational, analytical and problem-solving skills
Must have keen time management skills
Ability to work in a team proactively, flexibly in an environment
Education B.S. in Engineering
Minimum 4 years of experience in Reliability Engineering. 2+ years of experience working with medical device products and in the healthcare industry

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