Job Requirement Detail
Company : Optghar
Req/job Title : Lead System Engineering – (Electrical/ Electronics)
Job Ref No : 5925
Post Date : 03/06/2019
Country : USA
Job State/Province : Texas
Job City : TX
PrimarySkill : IT
Experience : 10 - 12
OtherSkill :
Subject : Lead System Engineering – (Electrical/ Electronics)
Description :

Job Description:

Graduate electrical/electronics engineer with 10-12 years’ experience

Must have worked on projects involving all the phases of medical device development for USFDA and European norms

Lead the effort for system engineering projects involving requirement analysis, elaboration on system, subsystem and elements involving hardware, software, accessories etc.

Able to generate and review system engineering strategy including what, when, why, who and how a medical device verification and validation is achieved.

Working knowledge on wireless protocols such as Bluetooth, Wi-Fi is preferred

Propose changes as essential and ensure test plans and reports are aligned to organization standard operating procedures regulatory requirements, client’s policies, procedures, program schedule and budget

Propose design changes and construct in-house tests to verify the product design features related to functionality and compliance

Provided strategic communication with other product team on system engineering and work with cross functional team to achieve project deliverables within targeted timelines

Awareness on safety, EMC, environmental/climatic impact, vibrations and shock impact etc. standards on various regulatory and certifying institutions like CE, ATEX, SIL, UL, IEC, CSA, TUV etc.

Knowledge on risk and hazard analysis tools and techniques such as HAZID, FMEA, FMECA, HAZOP, SWIFT is plus

Scripting knowledge to automate testing is preferred but not mandatory

 

Experience(s), education and knowledge required:

Excellent communication skills and the ability to work with the business and all project team members

Strong sense of ownership, with a passion for delivery

Should be a self-starter person who takes initiative to solve problems

Knowledge of Mobile Application(Preferred)