Engineer II, Manufacturing

Edwards Lifesciences; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Edwards Lifesciences Gruppe in Singapore seeks a Manufacturing/Process Engineer to optimize production, develop qualification experiments, and resolve CAPA and compliance issues. You will create training materials, lead project plans, and coordinate technicians in a fast-paced medical device environment.

The role requires a degree in Engineering or Science and 2 years of experience, with strong documentation and communication skills, and familiarity with FDA-related regulations a plus.

Qualifications

• Bachelor's or Master’s degree in Engineering or Science.
• 2 years of relevant engineering experience.
• Experience with lab/industrial equipment preferred.
• Strong documentation and communication skills.
• Knowledge of FDA medical device regulations a plus.

Responsibilities

• Optimize manufacturing processes using SIX Sigma and LEAN methods.
• Develop experiments and tests to qualify manufacturing processes.
• Analyze and resolve manufacturing and compliance issues (CAPA, non-conformances, audits).
• Create training materials and work instructions for production.
• Establish project plans and manage deliverables.
• Oversee manufacturing support tasks and coordinate technicians.
• Adhere to Leadership instructions and safety rules.

Skills

Project management

Statistical methods

Problem-solving

Communication skills

Teamwork

Education

Bachelor’s degree in Engineering or Science

Tools

CAD

MS Project

MS Office

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.How you will make an impact:• Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills• Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports• Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes• Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work• Other incidental duties assigned by LeadershipWhat you'll need (Required):• Bachelor's Degree in Engineering or Scientific field, 2 years of experience required or• Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education requiredWhat else we look for (Preferred):• Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills• Basic understanding of statistical techniques• Previous experience working with lab/industrial equipment required (if applicable)• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering• Solid problem-solving, organizational, analytical and critical thinking skills• Solid understanding of processes and equipment used in assigned work• Knowledge of applicable FDA regulations for medical device industry• Strict attention to detail• Ability to interact professionally with all organizational levels• Ability to manage competing priorities in a fast paced environment• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control