Technician, Maintenance & Manufacturing Support

Edwards Lifesciences Gruppe; United States; On-site; USD 44,000 - 63,000; Full time

Job summary

Edwards Lifesciences Gruppe is seeking a manufacturing-focused team member to support validation, maintenance, and documentation for critical cardiovascular devices. You will collaborate with engineering, perform preventive maintenance, and contribute to process improvements in a regulated medical device environment.

The role requires a high school diploma or Associate's degree with related experience, strong MS Office skills, and the ability to troubleshoot manufacturing equipment.

Qualifications

• H.S. Diploma or equivalent with 1 year related experience or Associate's Degree or equivalent.
• Strong computer skills and ability to navigate MS Office Suite.
• Ability to troubleshoot manufacturing equipment and follow protocols.

Responsibilities

• Execute experiments and tests to develop findings for validation and improvement of equipment and processes; analyze results and prepare reports.
• Collaborate with Engineering on equipment investigations and dispositions.
• Compile documentation for archives (ECRs, SOPs, drawings, tooling) for Engineering approval.
• Perform weekly preventive maintenance routines to avoid downtime and troubleshoot equipment.
• Check for failures in equipment and perform corrective actions with impact assessments.

Skills

Good computer skills

MS Office Suite

Communication skills

Troubleshooting equipment

Detail-oriented

Education

High School Diploma or equivalent

Associate's Degree or equivalent

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.

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.

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.

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.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.