Technologist, Transfer Projects

Imagine how your ideas and expertise can change a patients life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. Youll partner cross-functionally with manufacturing operations 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 will help bring life-changing products to patients by supporting the successful transfer of new products into manufacturing. Working closely with Transfer Engineering Operations and cross-functional partners youll provide technical expertise to ensure manufacturing readiness and contribute to smooth successful commercial launches.

How youll make an impact:
Troubleshoot and recommend maintenance to limit downtime to keep production on schedule and to ensure ongoing validation compliance.
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.
Collaborate with Quality in devising and implementing corrective actions exception work orders (EWOs) Equipment Non-conformance Reports (ENCRs) and Out of Tolerance (OOTs).
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.

What youll need (Required):
H.S. Diploma or equivalent with 6 years related experience or
Associates Degree or equivalent with 4 years related experience

What else we look for (Preferred):

Previous experience in manufacturing and/or medical device experience.
Strong written and verbal communication interpersonal and relationship building skills including formulating work instructions and providing guidance and training to lower-level employees with little to no direction.
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 Maximo); and CAD if applicable.
Full knowledge of validation and improvement of automated equipment.
Ability to troubleshoot manufacturing equipment.
Ability to understand the fundamentals of project management; Lead projects related to new equipment validation equipment investigations testing objective evidence of product dispositions and rework.
Full knowledge of routine preventive maintenance of production equipment and electrical mechanical electronic pneumatic and controls.
Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.
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.