Engineer II, Manufacturing

Edwards Lifesciences; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

Edwards Lifesciences Singapore is seeking a Manufacturing Engineer within Global Operations & Quality to optimize processes and support compliance for cardiovascular devices. You will contribute to continuous improvement initiatives, collaborating with cross-functional teams across manufacturing, QA, and sales.

The role requires a Bachelor’s or Master’s in Engineering/Science with relevant experience, strong documentation, and problem-solving skills.

Qualifications

• Bachelor's or Master's in Engineering/Science with relevant experience.
• Experience in manufacturing/quality environments preferred.
• Familiarity with FDA regulations for medical devices is a plus.

Responsibilities

• Optimize manufacturing processes using Six Sigma/LEAN to improve efficiency.
• Develop experiments and tests to qualify and validate processes; analyze results.
• Address CAPA/non-conformances and support audits and validation activities.
• Create training and work instructions for production staff.
• Plan projects with timelines and risk analyses to meet customer expectations.
• Supervise technicians and coordinate testing and data collection.
• Assist Leadership with additional duties as assigned.

Skills

LEAN Six Sigma

Manufacturing processes

CAPA & compliance

Documentation & training

Project management

Statistical techniques

Lab/industrial equipment

Education

Bachelor's degree in Engineering or Science

Master's degree with internship/thesis

Tools

MS Project

CAD

MS Office

Job description

Imagine how your ideas andexpertisecan change a patient’s life. Our GlobalOperations &Qualityteam plays a central part in ensuring our products are delivered to patients with cardiovascular disease.You’llpartner 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 Leadership

What you'll need (Required):

• Bachelor's Degree in Engineering or Scientific field, 2 years 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 Required

What 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