广州招聘

职位描述：
POSITION DESCRIPTION

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.
The candidate should feel comfortable dealing with ambiguity, and confident about being able to apply engineering experience and seniors to make pragmatic choices about design, manufacturing, and quality system processes. They should have great communication and collaboration skills.

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POSITION RESPONSIBILITIES
？ Essential Functions of system engineer:
？ Lead 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.
？ Lead 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.
？ Supports hardware, software and systems level verification and validation testing.
？ May work on process improvement activities.

？ Lead new product development from concept to commercial launch. Lead team to Create concepts and prototypes for mechanical and related components.
？ Manage technical communication and connection with ST SBUs.
？ Work with marketing for ST new opportunity identification and development. Participate in building up ST access portfolio in China.
？ Work with the RA to understand regulatory requirement and complete relevant testing and report to support product registration. Be involved in product type testing preparation and implementation.
？ Maintain awareness of current technological developments and accepted industry standards
？ Other duties as assigned with or without accommodation.
？ Some level of travel across China will be required to visit vendors and attend relevant conferences.

JOB QUALIFICATIONS

Education:
BS of mechanical or electronic engineering, MS preferred

Experience:
? BS degree in engineering with minimum 5 years complex, multi-disciplined product development, or MS degree in engineering with minimum 3 years applicable experience
? Sound experience in designing, processing, testing and manufacturing of mechanical &electronic components/products in the medical device area

Skills/Qualifications:
? Experience as a systems/product engineer in medical device industry
? 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.
? Fluency in English and Mandarin required

Skills/Competencies:
? Analytical, problem solving and negotiation skills.
? Good interpersonal, written and verbal communication skills
? Self-starter and capable of working with minimal supervision. Ability to manage multi-task across multiple projects.

MEDTRONIC BACKGROUND
? Medtronic is a mission-based company. Our products save lives and improve quality of life for millions of patients around the world.
? The MSIC will help to develop the local capabilities for creating these products in China, for China, which will move Medtronic China towards a fully multi-functional business and improve the level of medical technology available in China.
? R&D is a very important part of the Medtronic business. We spend approximately 10% of revenue on R&D each year.
? Our commitment to China is strong and we anticipate growth each year in our Shanghai R&D operation.

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.