Company seeking someone at an early stage in their career, ideally with 1 – 4 years of industry experience, preferably medical device or another similar regulated environment.
Excellent Career Opportunity for the right person.
As Associate Maintenance Technician, you will have a strong ability to work independently to support Operations and Engineering.
- 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
- Lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework
- Perform both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program downtime
- Check for failures in more complex equipment and processes, and perform corrective actions to affected areas that have downtime, 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
- Utilize manufacturing software (e.g., JDE, QMS,PLM) to update the documentation in systems
Required Education & Skills:
- Associate’s degree with a minimum of 1 year and maximum of 4 years experience in manufacturing and/or related medical device experience
- 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
- Ability to troubleshoot manufacturing equipment
- Basic knowledge of material compatibility in the proposed use environment
- Moderate knowledge of routine preventive maintenance of production equipment
- Moderate knowledge electrical, mechanical, electronic, pneumatic, and controls
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department cleanroom medical device manufacturing
- Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
- Strict attention to detail
- Must be able to work under limited supervision
- Adhere to all EHS rules and requirements 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
If you wish to discuss this role in confidence please contact Deirdre Sheehan.