Staff Technologist ,Maintenance/Manufacturing Support Engineer

Edwards Lifesciences (Singapore) Pte Ltd; Singapore; On-site; SGD 70,000 - 120,000; Full time

Job summary

Edwards Lifesciences (Singapore) Pte Ltd is seeking a Subject Matter Expert to drive asset management, equipment maintenance and manufacturing support activities on the shop floor. You will lead feasibility studies, experiments and tests, and develop findings for validation and process improvement.

In this role you will manage projects using MS Project and Gantt charts, collaborate on CAPA investigations, and ensure documentation is correctly transferred to ECRs, SOPs, drawings and PLM systems.

Qualifications

• Diploma or equivalent in a related field.
• 15 years related experience in manufacturing or medical devices.
• Experience in manufacturing and/or medical device environments.

Responsibilities

• Provide SME with in-depth knowledge in asset management and equipment maintenance.
• Design, set-up, and execute complex feasibility studies and tests per protocols.
• Manage project scope, schedule and resources using MS Project and Gantt charts.
• Collaborate with Engineering on systemic root-cause investigations for CAPA.
• Review documentation and ensure validation/qualification of equipment.
• Lead development of new tools/equipment for multiple areas.
• Design, develop and sustain processes and procedures and train users.
• Update documentation in systems (ECRs, SOPs, drawings, PLM).
• Provide coaching and guidance to technicians.

Skills

Asset management

Equipment maintenance

Manufacturing support

Engineering collaboration

Education

Diploma or equivalent

Tools

Microsoft Project

Gantt charts

JDE

QMS

PLM

Job description

Key Responsibilities

• Key SME (Subject Matter Expert) with in-depth knowledge and technical proficiency in asset management, equipment maintenance, and manufacturing support activities
• Design, set-up, and execute complex feasibility studies, experiments, and tests - both creating and following established protocols - to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review
• Manage all aspects of project management, using such tools as Microsoft Project, Gantt charts, etc., to ensure on-time and on-budget project completion, including interfacing with all parties, allocating resources, negotiating competing priorities, mediating conflicting objectives, and escalating issues as needed for resolution
• Collaborate with Engineering on systemic root cause investigations for CAPA
• Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval
• Lead projects to develop new complex tools/equipment for implementation in multiple areas
• Design, develop and sustain processes and procedures, including methods to train users
• Utilize manufacturing software (e.g., JDE, QMS, PLM) to update documentation in systems (e.g., ECRs, Blue Mountain)
• Provide coaching and guidance to technicians

Education and Experience

• Diploma or equivalent 15 years experience related experience
• Previous experience in manufacturing and/or medical device experience \