- 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.
- 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.
Required Job Skills