Job Description

Imagine how your ideas andexpertisecan change a patient’s life. Our GlobalOperations &Qualityteam plays a central part in ensuring our products are delivered to patients with cardiovascular disease.You’llpartner 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.

In this role, you'll leverage your technical expertise to support manufacturing operations that ultimately help improve patient lives. The Senior Technologist role partners with Operations and Engineering teams to implement solutions, enhance processes, and provide mentorship to junior technicians, helping both people and processes succeed.

*The standard hours for this role are 1st shift 4/10 schedule Monday-Thursday starting at 5am. Potential flexibility for 1st shift 5/8 schedule Monday-Friday.

How you'll make an impact:
• SME (Subject Matter Expert) with in-depth knowledge and technical proficiency in asset management, equipment maintenance, and manufacturing support activities.
• Design, set-up and execute complex 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.
• 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.
• Perform primarily unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program down time, including providing expertise and guidance in resolving complex failures.
• Apply in-depth knowledge of processes in the use of machines to ensure successful outcomes, devise complex process changes, and ensure knowledge transfer to other levels of technicians.
• 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 10 years related experience required or
• Associate's Degree or equivalent 8 years related experience required
• Previous experience in manufacturing and/or medical device experience required

What else we look for:
• Excellent written and verbal communication, interpersonal, and relationship building skills with focus on influencing and conveying recommendations.

• Collaborate with Engineering and CAD/Designers to develop new complex tools/equipment and product/process root cause investigations.
• Strong computer skills, including usage of MS Office Suite; Utilizing manufacturing software (e.g., JDE, QMS, PLM) to update documentation in systems (e.g., ECRs, Maximo)and CAD if applicable.

• Lead and manage projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework.
• Extensive knowledge of routine preventive maintenance of production equipment and electrical, mechanical, pneumatic and controls.
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.

• Troubleshoot, as well as anticipate issues, and propose solutions to limit downtime and keep production on schedule.

• 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, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs).
• Must be able to work independently in completing assigned projects, developing work instructions, and advancing the competency of other technicians.

• May source basic new equipment for implementation into manufacturing.
• 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.

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

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.