Project Engineer (Medical Device)

FINDTALENT JSC

Mô tả công việc

  • Perform the project management responsibilities for engineering activities within the New Product Development (NPD) team
  • 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
  • Provide visibility to project schedule and budget issues and 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 
  • Assess and highlight risks and develops mitigation plans – active participant in the risk management ext process
  • Ensure good cross-functional communication (through effective meetings, email, and other means) to coordination between Engineering functional areas and other departments.
  • 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 (test procedures, drawings, BOMs).
  • Perform post-mortem reviews on key developments and leads communication of further design improvements to projects
  • Interpret, implement, and monitor modifications to department methods, processes and policie that affect multiple work groups
  • Provide input and plans for program related expense to the engineering, quotations, budget development and forecasting
  • Carry out other duties as and when assigned by the management.

Yêu cầu công việc

  • Bachelor’s degree or higher in the Engineering field (Computer Science, Computer Engineering, Electrical Engineering preferred) or related technical degree.
  • At least 06 years of total medical device development experience with at least 03 years previous project management experience.
  • Strong competence with the various project management tools, procedures, programming languages used to accomplish the job.
  • Excellent written and verbal communication skills (ability to speak and/or read Mandarin a benefit).
  • Ability to translate, statistically analyze data, and effectively report problems through written and/or graphical formats.
  • Excellent customer service skills, with an advanced understanding of internal and external customer relationship building.
  • Ability to use MS Word, Excel, PowerPoint, Project (Celaxis and Epicor knowledge a benefit).
  • Engineering (electromechanical) experience, training, and knowledge to be able to understand and communicate effectively with the engineering teams, and to check/review their plans and progress.
  • Ability to adapt processes to improve inefficiencies and accelerate outcomes.
  • Strong knowledge of ISO 13485 and cGMP product development requirements.

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