Coordinate new product development with customers and internal project teams;
Work with engineering team leads and management to create and tracks schedules, budgets, performance targets, resource plans, prioritization and delegation of tasks, and general planning activities for engineering deliverables;
Manage escalation and coordinate critical issue resolution with project engineering Team Lead, Business Development Manager and Engineering Management;
Provide the project management interface to project leads as well as critical internal and external (client) stakeholders for efficient coordination, execution of critical activities and project management functions;
Review design and determine required bill of materials;
Work with supply chain to obtain bill of materials pricing (from internal and external vendors);
Draft quotations and project scopes for review by management and delivery to customer.
Help to conduct component and device testing protocols.
Help to develop plans to evaluate process repeatability and stability through equipment qualification and process validation;
Work with various departments and multiple manufacturing sites to facilitate pilot production of new products;
Ensure successful completion of project stages gates and related activities required for the projects to comply with the company ISO 13485 / cGMP compliant design and development process;
Ensure proper documentation is completed for each development activity, and that adequate documentation exists for the Design History File, product manufacturing and ongoing production documentation;
Perform other related duties as assigned by management.
Yêu cầu công việc
Bachelor's Degree in Engineering (Electrical, Mechanical, Biomed or Software acceptable);
Two to five years experience with medical device and integrated systems required;
Excellent written and oral communication skills;
Ability to manage priorities and workflow;
Ability to coordinate and flexibility to attend meetings across multiple time zones (Asia/Americas);
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm;
Acute attention to detail;
Proven ability to handle multiple projects and meet deadlines;
Good judgement with the ability to make timely and sound decisions;
Working knowledge of data collection, data analysis, evaluation, and scientific method.