Technician, Maintenance & Manufacturing Support

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 44,000 - 63,000; Full time

Benefits offered by this job

Competitive salary

Job summary

Edwards Lifesciences Irvine is seeking a Maintenance & Manufacturing Support Technician to provide technical support for Operations and Engineering. You will execute experiments, support equipment validation, and collaborate with Engineering on investigations.

The role requires a high school diploma or associate's degree with relevant experience, strong documentation practices, and the ability to troubleshoot manufacturing equipment in a regulated medical device environment.

Qualifications

• Must have high attention to detail and ability to follow GMP documentation practices.
• Experience with manufacturing equipment validation and process improvement.
• Ability to troubleshoot manufacturing equipment and perform basic maintenance.
• Familiarity with manufacturing software to update system documentation.

Responsibilities

• Execute tests and experiments to support validation and improvement of equipment and processes.
• Collaborate with Engineering on equipment investigations and dispositions.
• Prepare documentation for archives including ECRs, SOPs, drawings, and tooling.
• Perform weekly preventive maintenance and troubleshoot down-time related issues.
• Adhere to safety, quality, and environmental protocols.

Skills

Computer skills

MS Office

Equipment troubleshooting

Preventive maintenance

Documentation & GMP knowledge

Validation & equipment improvement

Education

Associate's degree or equivalent

High School Diploma or equivalent with 1 year related experience

Tools

JDE

QMS

PLM

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.The Maintenance & Manufacturing Support Technician provides technical and function-specific knowledge to support Operations and Engineering activities.How you'll make an impact:• Execute experiments and tests (following 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.• Collaborate with Engineering on equipment investigations, testing, objective evidence of product dispositions and rework.• Compile documentation for archives to ensure appropriate documentation for development work, including ECRs, SOPs, drawings, and tooling, for Engineering approval.• Perform weekly preventive maintenance routines for equipment to avoid program down time and troubleshoot basic manufacturing equipment.• Check for failures in equipment and perform corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents.• Other incidental duties.What you'll need (Required):• H.S. Diploma or equivalent with 1 year related experience.or• Associate's Degree or equivalent.What else we look for (Preferred):• Good computer skills, including usage of MS Office Suite.• Basic written and verbal communication, interpersonal, and relationship building skills.• Moderate knowledge of validation and improvement of automated equipment.• Ability to troubleshoot manufacturing equipment.• Basic knowledge of material compatibility in the proposed use environment.• Moderate knowledge of routine preventive maintenance of production equipment, electrical, mechanical, electronic, pneumatic, and controls.• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment, utilizing manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems.• Strict attention to detail.• Must be able to work under limited supervision.• 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.Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California (CA), the base pay range for this position is $44,000 to $63,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.