Project Manager (Medical Device Industry)


Job description

  • 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.

Job Requirement

  • 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

production management schedules delegation planning pricing manufacturing pilot software communication sound analysis