(in Yrs) 6+
? 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