Process Development Engineer 2

Position Summary

1.    Proactive in design and technical phase reviews and discussion. 
2.    Actively contribute in process development activities includes designing the process, evaluating and optimizing the product design and manufacturing process thru Design For Excellence. DFX activity include manufacturing (DFM), cost (DFC), assembly (DFA) and testability (DFT). 
3.    Perform stack up analysis on fitting and assembly to finalize critical point (EDO)
4.    Carry out tolerance review on 2D / 3D on part level & assembly level.
5.    Perform DOE to define process parameter window, set up and qualify process equipment by performing process validation activity.
6.    Conduct statistical analysis for process stability monitoring & seek opportunity of cycle time and productivity improvement using process capability study (Cpk), Design of Experiment (DOE), Statistical Process Control (SPC) tools etc 
7.    Support PFMEA and risk assessment for new product and manufacturing process 
8.    Transform laboratory process (manual) towards up to date HVM manufacturing process. Process development by considering poka-yoke, LEAN and any new technology advancement.
9.    Exploring new tools, jig & fixture and automation of machinery during assembly process development. 
10.    Conduct proof of concept (POC) to ensure process stability at initial development phase.
11.    Drive improvement for critical process like Extrusion, Moulding, Tip Forming, Eye Punching, Tube Surface Coating, Packaging technology & Sterilization stability.
12.    Assessing consistency of measuring method & equipment accuracy & repeatability.
13.    Drive improvement related to packaging process.
14.    Tooling review to ensure product meeting design requirement and stability of quality.
15.    Tracking project schedule, status updates, project database reporting and other project documentation. Project can be either independent efforts or an input to a larger project plan maintained by others project leaders
16.    Generate the project validation plan and IQ/OQ/PQ protocol, execute the validation activity to qualify the equipment and assembly processes (especially on new process development) by closing the validation report and relevant documentation.
17.    Coordinate sample build planning and assemble samples for evaluation purpose. 
18.    Ensure changes are implement though Engineering Change Notice (ECN).
19.    To ensure the implementation and maintenance within the workplace of an effective management for occupational safety and health with the Occupational Safety and Health Act 1994 and other legislative requirements.
20.    Ensure program conforms to the Quality System Regulation (QSR), CMDCAS, MDD 93/42/EEC, MDR, ISO 13485 and other relevant standards.

Principal Responsibilities

Education / Experience Requirements

Qualification  :

Bachelor’s Degree in Mechanical Engineering or equivalent technical discipline, or an advanced degree, or equivalent work experience.

Experience :

a) Minimum 3 years working experience, preferably in a Medical Device / Manufacturing Industries and demonstrated expertise or with in-depth knowledge in relevant Engineering discipline and Project Management.

b) Knowledgeable on effective and efficient product manufacturing processes.

c) Have strong technical and problem-solving skills to ensure optimal project execution and implementation.

d) Must have a sense of urgency and commitment to project schedules. Take it is a challenge to work in a dynamic international environment.

e) It will be an advantage to have relevant experience from the Medical Device industry including FDA requirements, Design Control, Process Validation and ISO 13485.

Specialized Skills / Other Requirements