Job Title System Engineer
(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