常州招聘

职位描述：
POSITION DESCRIPTION
Following the Project Management Excellence methodology, the Project Engineer, is responsible for the creation, implementation, reporting and communication of new product project plans. Project Engineer will also be responsible for ensuring plans and deliverables are compliant with appropriate design control procedures.
1. This individual will work with R&D, Technical, quality, RA and other functions to successfully organize and lead project teams focused on developing and commercializing innovative new products for the local and the emerging market.
2. Utilize PMEx methodology to develop project timelines and track project progress
3. Maintain a detailed working knowledge of all R&D policies and procedures. Ensure that project team is planning and executing projects according to procedures
4. Encourage teamwork and foster collaboration across functional departments

POSITION RESPONSIBILITIES
Ideal candidate will have overall system engineering and project management skills, medical device product development experience, and a thorough understanding of local regulatory agency requirements.
Candidate will have the ability to work cross-functionally to:
1. Generate detailed and accurate, risk adjusted project plans with the buy in of project core team members and all related key stakeholders
2. Plan, coordinate and track project activities
3. Anticipate project roadblocks and generate plans to overcome project related obstacles
4. Effectively communicate project status, risks, and issues to project team and key stakeholders
5. Proactively escalate issues in need of management’s attention or even to be involved
6. Ensure that the Project Design History File is current & accurate, and manage documentation & communication needs for the project, ensuring all regulatory standards are met
7. Able to independently determine and develop proactive approaches to solutions.
8. Support Core Team meetings by preparing the agenda, project updates, taking meeting minutes
9. Effectively handle conflict through proactive action, and direct and timely communication

BASIC QUALIFICATIONS
EDUCATION AND EXPERIENCE REQUIRED
1. BS in engineering, such as mechanical engineering, materials engineering, biomedical engineering or similar related field
2. 5+ years of combined experience as a R&D engineer and project management in the Medical Technology, health care or other technical disciplines
SPECIALIZED KNOWLEDGE REQUIRED
1. Project management skills.
2. Excellent interpersonal, written and verbal communication skills
3. Execution oriented, driven and self-motivated
4. Speak and write Mandarin and English fluently
5. Ability to work independently( self-directed)
6. Strong Microsoft Project skills
DESIRED/PREFERRED QUALIFICATIONS
1. R&D or project management experience in the area of orthopedic devices (spine, joints, trauma, etc.)
2. PMP certification
3. BS with 5+ years of experience in the health care industry sector
4. Be familiar with QMS13485 and other regulations & standards etc. 举报 分享

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