Technologist, Maint/Mfg Support Eng

Edwards Lifesciences; Salt Lake City, Northern (UT, KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Edwards Lifesciences in Salt Lake City is seeking a Maintenance and Manufacturing Support Technologist to provide technical manufacturing support to Operations and Engineering. You will help optimize equipment and processes, manage documentation, and support validation activities to ensure compliant production of medical devices.

The role requires strong problem-solving skills, knowledge of preventive maintenance, and collaboration with cross-functional teams.

Qualifications

• H.S. Diploma or equivalent with 6 years related experience or Associate's Degree with 4 years related experience.
• Previous experience in manufacturing and/or medical device experience preferred.
• Strong written and verbal communication, interpersonal, and relationship building skills.
• GDP (Good Documentation Practices) knowledge and adherence.

Responsibilities

• Design, set-up and execute feasibility studies, experiments, and tests - both creating and following established 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.
• Perform both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program down time.
• Check for failures in more complex equipment and processes, and perform corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents.
• Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval.
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.
• Other incidental duties (e.g. occasional photo copying or deliveries).

Skills

Preventive maintenance

Documentation practices

Troubleshooting equipment

Cross-functional collaboration

CAD collaboration

Education

H.S. Diploma or equivalent

Associate's Degree or equivalent

Tools

JDE

QMS

PLM

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.

The Maintenance and Manufacturing Support Technologist provide technical manufacturing support to Operations and Engineering.

*The standard hours for this role are 1st shift 4/10 Monday-Thursday starting at 5am.

How you'll make an impact:

• Design, set-up and execute feasibility studies, experiments, and tests - both creating and following established 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.


• Perform both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program down time.


• Check for failures in more complex equipment and processes, and perform corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents.


• Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval.


• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.


• Other incidental duties (e.g. occasional photo copying or deliveries).

What you'll need:

• H.S. Diploma or equivalent 6 years related experience required or


• Associate's Degree or equivalent 4 years related experience required

What else we look for:

• Previous experience in manufacturing and/or medical device experience preferred.


• Strong written and verbal communication, interpersonal, and relationship building skills.


• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices).


• Strong computer skills, including usage of MS Office Suite; manufacturing software (JDE, QMS, PLM) to update documentation; and CAD if applicable.


• Lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework.


• Ability to troubleshoot manufacturing equipment.


• Collaborate with Engineering and CAD/Designers to develop new basic tools.


• Full knowledge of routine preventive maintenance of production equipment, electrical, mechanical, pneumatic, and controls.


• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.


• Collaborate with Quality in devising and implementing corrective actions, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs).


• 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.