System Engineer- Process


Milpitas, CA

Industry: IT Consulting/Services


5 - 7 years

Posted 299 days ago

  by    Pratap jiandani

This job is no longer available.

elevant Experience 

(in Yrs) 6+

Technical/Functional Skills

? Working experience in system engineering field


? Understanding of ISO13485, ISO14971, IEC 60601, IEC 62366, FDA 21 CFR Part 820, and FDA human factors guidance

? Basic knowledge of medical terms, anatomy, physiology, and procedures 

? Minimum 5years work related systems engineeringexperiencerequired

? 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 concernwithin analysis.

? Develop FMEA with assistance from the Design Team.

? Analyze failure modes, riskassociated 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 withIndustrial 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


? B.S. in Engineering

? Minimum 4years of experience in ReliabilityEngineering. 2+ years of experienceworking with medical device products and in the healthcare industry

$90K - $100K