About this role
Provide technical manufacturing support to Operations and Engineering. Key Responsibilities: • Key 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 • Manage all aspects of project management, using such tools as Microsoft Project, Gantt charts, etc., to ensure on-time and on-budget project completion, including interfacing with all parties, allocating resources, negotiating competing priorities, mediating conflicting objectives, and escalating issues as needed for resolution • Collaborate with Engineering on systemic root cause investigations for CAPA • 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 • Lead projects to develop new complex tools/equipment for implementation in multiple areas • Design, develop and sustain processes and procedures, including methods to train users • Utilize manufacturing software (e.g., JDE, QMS, PLM) to update documentation in systems (e.g., ECRs, Blue Mountain) • Provide coaching and guidance to 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) Education and Experience: • H.S. Diploma or equivalent; 15 years of related experience required or • Associate's Degree or equivalent; 13 years of related experience required • 15 years of previous experience in manufacturing and/or medical device experience preferred Additional Skills: • Excellent written and verbal communication, interpersonal, and relationship building skills with focus on creating presentations, influencing and conveying recommendations • Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices) • Strong computer skills, including usage of MS Office Suite; and CAD if applicable • Extensive knowledge of validation and improvement of automated equipment • Ability to troubleshoot manufacturing equipment • Knowledge of material compatibility in the proposed use environment • Ability to execute the fundamentals of project management • Extensive knowledge of routine preventive maintenance of production equipment • Extensive 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 • Must be able to work independently in completing complex projects, developing work instructions, and providing guidance to advance the competency of other technicians • 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