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.
Job Requirement
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.