職位描述
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.
Job Purpose
POSITION DESCRIPTION
The Program Manager will provide overall tactical and organizational leadership for local product development activities within China and across the Asia / Pacific for the Surgical Technologies (ST) sector.
This position is responsible for all activities across the product development lifecycle, with a focus on bringing new products to market that meet the local market needs. This person will ensure that both business unit and MSIC objectives are met while working collaboratively across the organization to establish the systems and processes required to support new product development locally. This position requires coordination and collaboration of activities with local management and sector management within Surgical Technologies.
They should feel comfortable dealing with ambiguity, and confident about being able to apply business acumen to make pragmatic trade-off decisions between time-to-market, product costs, product reliability, product features, and budget. They should have great communication and collaboration skills. Past experience developing, delivering, deploying and maintaining medical devices is required for this position. Under local management, they will need to have the ability to work remotely and independently with adequate levels of technical direction and support provided by ST sector in US.
This position requires partnering with business unit and marketing teams to understand local market needs. Must travel and meet with customers to identify unmet clinical needs and new product opportunities.
Responsibilities
Ideal candidate will have overall 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:
Partner with local functions to establish local quality system processes and controls; fully utilize the system for product development process
Establish network with local biomedical community
Establish OEM relationships to produce medical devices locally
Partner with local functions to establish processes and controls to allow local and regional distribution
Lead core team to gain agency approvals (e.g. SFDA) to market products within China and export products to markets within other Asia/Pacific markets
Lead core team to create local quality system documentation
Device master records
Design history files
Device history records
Etcetera
Additionally, the candidate will be responsible to:
Initiate and plan the scope, schedule, resources and costs of assigned projects.
Ensure project teams are effective and successful in the execution of project plans.
Identify and articulate the risks and counter measures associated with the project plan.
Apply and demonstrate strong leader skills that result in a collaborative culture using clear, credible, objective and proactive communications and stakeholder management throughout the product development life cycle.
Ensure design and compliance requirements are met.
Produce, distribute and present timely periodic reports of project status and other reports as requested.
Qualifications
BASIC QUALIFICATIONS
EDUCATION AND EXPERIENCE REQUIRED
B.S./B.A. in Engineering or similar related field
8+ Years of Exp
