Sr Tech, Maint/Mfg Support Eng

Provide technical manufacturing support to Operations and Engineering.
Key Responsibilities:
• 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
• Troubleshoot basic manufacturing equipment
• May lead small projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework
• Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems
• Provide coaching and guidance to technicians
• Other incidental duties
Education and Experience:
H.S. Diploma or equivalent 4 years years experience related experience Required or
Associate's Degree or equivalent 2 Years years experience related experience Required
previous experience in manufacturing and/or medical device experience Preferred
Additional Skills:
• 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 clean room 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 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.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.