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:
• Perform weekly preventive maintenance routines for equipment to avoid program down time.
• 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.
• 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.
• 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.
• Identify potential improvement opportunities and propose solutions to optimize equipment, e.g., re-design/design of basic equipment, tools, fixtures, for Engineering review.
• Other incidental duties.

What you'll need:
• H.S. Diploma or equivalent with 4 years related experience required or
• Associate's Degree or equivalent with 2 years related experience required.

What else we look for:
• Previous experience in manufacturing and/or medical device experience preferred.

• Good written and verbal communication, interpersonal, and relationship building skills.
• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices).
• Good computer skills, including usage of MS Office Suite.
• Moderate knowledge of validation and improvement of automated equipment.
• Moderate knowledge of trouble shooting and routine preventive maintenance of production equipment, electrical, mechanical, electronic, pneumatic, and controls.

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

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