北京招聘

POSITION RESPONSIBILITIES

Essential Functions of Principle System Engineer:

• Lead the Robotics related product 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.
• Support Manager on robotic surgery technology and create roadmap of Robotic Platform and assistant the project pipeline creation.
• Go to hospital and talk with surgeons and observe the surgery in OR, hear the Voice of Customer and identify unmet needs of robotic surgery
• 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 (i.e. software, electrical, mechanical, reliability, manufacturing, service, quality, etc.) to resolve system / interface issues by evaluating overall systems performance / function.
• Monitor systems level verification and validation testing under the support of V&V team.
• Be a surgical robotics domain expert to develop (Organically or Inorganically) new product from concept to commercial launch. Lead R&D team to Create concepts and prototypes.
• Manage communication and connection with Global BUs.
• Work with global marketing for new opportunity identification and development.
• Work with QA, PMO Sourcing team to identify the technical specification and lead product engineering.
• Work with the RA to understand regulatory requirement and lead to complete relevant testing and report to support product registration. Be involved in product type testing preparation and implementation.
• Maintain awareness of current medical robotic technological developments and accepted industry standards
• Work cross inside and outside multiple function project team and be the overall system lead
• Other duties as assigned with or without accommodation.
• 30% of time on travel world widely will be required to visit GBUs hospitals, partners and attend relevant conferences or seminar

JOB QUALIFICATIONS

Education:

MS of EE, BMO, CS, Industry Automation, Mathematics. Or other medical/surgical related areas.

Ph.D is desirable.

Experience:

· 7+ years of system engineering on medical equipment and development for complex, multi-disciplined product development, or PhD degree in engineering with minimum 5 years applicable experience

· Has 3+ years’ experience working on robotics related system design

· Be familiar with ISO13485 required medical device development process. Be familiar to IEC 60601-1-2 and others is a plus

· Experience in designing, processing, testing and manufacturing of mechanical &electronic components/products and QMS for medical device.

Skills/Qualifications:

· Product design/ engineering / verification for medical device industry

· Broad technical experience across disciplines including electrical, mechanical, software and visualization, 3D advanced visualization is a plus.

· Familiar with robotics surgery related therapies , specialties and operation procedures

· 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.

· know-how of manufacturing of medical equipment/instrument is a plus

· Fluency in English and Mandarin required, Good presentation skill is required

Skills/Competencies:

· Certificated 6-Sigma Black Belt will be desired.

· Strong analytical, problem solving skills.

· Excellent interpersonal, written and verbal communication & negotiation skills

· Self-starter and capable of working with minimal supervision.

· Ability to manage multi-task across multiple projects.

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.