南京招聘

Senior Systems Engineer(美国医疗设备行业巨头，新建亚太区研发中心,薪资优厚，有海外培训机会)

Reporting line:
Systems Engineering Mgr

Summary:
The Senior Systems Engineer is responsible for the development and management of integrated requirements for medical device products. This individual will participate in the creation of product requirements, high level systems architecture, mechanical and electrical requirements, hardware and software requirements, as well as the verification test procedures, Validation test procedures and other project documentation to ensure that mechanical, electrical and software subsystems function reliably as an integrated system.

Essential Functions:
Adheres to defined development processes and procedures. Participates in the development of system requirements and architecture, as well as the risk management principles and traceability that support the development and life cycle management of the product.
Flows down system requirements to sub-systems, defines subsystem architectures, and specifies module / component / user interfaces, by applying systems engineering processes.
Participates in and/or conducts technical reviews as defined in a structured, multi-stage product development process.
Participates in the development, review, and revision of procedures to support the use of systems engineering and risk management methodologies.
Works with other functional team members to generate integration and system test plans, creates and executes system level Verification and Validation test procedures.
Works with other functional team members (i.e. software, electrical, mechanical, reliability, manufacturing, service, quality, etc.) to resolve system / interface issues by evaluating overall systems performance / function.
Participates in other activities, such as performing hazard and risk analysis, reviews of designs and tests, etc.
Supports hardware, software and systems level verification and validation testing.
May work on process improvement activities.
Other duties as assigned with or without accommodation.

Job Qualification:

Education:
BS Engineering (Scientific or Technical discipline), MS preferred

Experience:
BS degree in engineering with minimum 5 years applicable experience, or
MS degree in engineering with minimum 3 years applicable experience, or
PhD with minimum 1 year applicable experience;
preferably in a regulated industry (i.e. medical, aeronautics, nuclear).

Skills/Qualifications:

Experience as a systems/product engineer preferably in a regulated industry (i.e. medical, aeronautics, nuclear, etc.).
Broad technical experience across disciplines including electrical, mechanical and software engineering.
Familiar with systems engineering processes, in particular top down design using system requirements.
Working knowledge of risk management techniques. (i.e. Risk Analysis, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), etc.).
Experience in the development of processes and procedures which integrate systems engineering and risk management methods.
Familiarity with ISO, Medical Device Directive, and other international medical device requirements and standards.
Experience in medical device design desirable.
Familiarity with SFDA quality systems regulations preferred.
Familiarity with FDA quality systems regulations preferred.

Skills/Competencies:
Strong analytical, problem solving and negotiation skills.
Strong interpersonal skills with ability to work with various business functions (Marketing, Operations, Quality, Service, etc).
Able to work in a cross functional team environment.
Good oral and written communication skills, especially technical writing.
Self-starter and capable of working with minimal supervision. Ability to multi-task across multiple projects.
Six Sigma or DFSS experience preferred.
Fluency in English and Mandarin required.

DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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