Engineer II, Manufacturing, Equipment Maintenance

Edwards Lifesciences Gruppe; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Edwards Lifesciences in Singapore is seeking a Manufacturing/Process Engineer to join Global Operations & Quality. You will drive process optimization using Six Sigma and LEAN, develop experiments, and qualify manufacturing processes to meet stringent quality standards.

The role requires a degree in Engineering or Science and 3–4 years of related experience, with strong documentation and cross-functional collaboration skills for a medical device environment.

Qualifications

• Bachelor's degree in Engineering or Scientific field with relevant experience.
• Advanced degrees or PhD are considered advantageous.
• Strong documentation, communication, and interpersonal skills.

Responsibilities

• Identify and implement opportunities to optimize manufacturing processes using Six Sigma and LEAN methods.
• Develop experiments and tests to qualify and validate processes and analyze results.
• Address CAPA, non-conformances, and audit observations in manufacturing.
• Create training/documentation materials for production to enable knowledge transfer.
• Lead project plans and coordinate teams to meet customer expectations.

Skills

Project management

Documentation

Communication

Problem-solving

Team collaboration

Education

Bachelor's degree in Engineering or Scientific field

Master's degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Tools

MS Project

CAD

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:• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards• Develop 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 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• Lead and 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 with, 4 years of experience including either industry or industry/education required or• Master's Degree or equivalent in Engineering or Scientific field with 3 years experience of experience including either industry or industry/education required or• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education requiredWhat else we look for (Preferred):• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)• Strong 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)• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering• Strong problem-solving, organizational, analytical and critical thinking skills• Substantial understanding of processes and equipment used in assigned work• Good leadership skills and ability to influence change• 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 inter-departmental teams and key contact representing the organization on contracts or projects• 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.