Senior Manufacturing Engineer

Essential Duties and Responsibilities:

• Responsible to support product and technology transfer from other Haemonetics sites to Penang
• As the technical lead for all assembly process improvement activities, inclusive of the manual assembly, semi-automated and fully-automated processes and equipment
• Direct, communicate, and manage projects including but not limited to design and engineering improvement of assembly processes, solvent bonding, plastic welding, heat sealing, harness tubing coiling and cutting, label printing, leak testing, etc.
• Support Validation Master Plan, execute a series of process validation, inclusive of protocol and test script writing, sample preparation, training, data analysis and report compilation
• Coordinate and execute all relevant engineering change work flow, drawing and documentation update in accordance to the SOP
• Deliver validation and all assigned tasks in a timely manner with close progress update, escalate issue and recommend mitigation plan towards meeting project timeline
• Organize, attend and participate in stakeholder meetings and teleconferences wherever required
• Document and follow up on important actions and decisions from meetings
• Prepare necessary presentation materials for meetings and progress report

Requirements:

• Candidate must possess at least Degree in any engineering or science discipline
• At least 5 year(s) of working experience in manufacturing or project management, preferably in medical device or pharmaceutical industry
• Sound knowledge and practical experience in medical device process validation IQ/OQ/PQ
• Preferably candidate with working experience in medical device assembly & packaging qualification
• Experience with statistics – able to apply statistical analysis software e.g. Minitab
• Good understanding of cGMP compliance and associated legislative standards for medical device i.e. ISO 13485, FDA 21 CFR Part 820, or equivalent
• Team player and able to work in fast pace project environment, liaising with multiple project stakeholders working towards aggressive deadline
• Good interpersonal and communication with sound presentation skill