Published: September 11, 2017
- Develop and maintain manufacturing processes including test/assembly equipment and recommend preventive maintenance to maintain the manufacturing performance at high level.
- Evaluate current test/assembly equipment and process performance and establish preventive and corrective action to assure process in optimum conditions avoiding downtime. Recommend a new equipment or technology for Business Continuity or Continuous Improvement.
- Provide day to day technical support and troubleshooting for multiple production processes and lead or support implementation of medium to high complex manufacturing solutions in pursuit of improved process control, increased throughput/productivity and reduced manufacturing cost. Designs fixtures, tools and manufacturing aids required for the assembly and of the product.
- Design and implement validations for processes and / or equipment using statistical tools and process control including preparation and participation in technical reviews.
- Supervise other engineers and/or technicians including maintenance technician
- Promote Value Improvement Projects (VIP) through lean events such as kaizen and applies knowledge of lean tools, 6S (six s), Six Sigma.
- Provide training, coaching, guidance, and information as requested and needed
- Other incidental duties: Participate in lean events; update knowledge and applications of lean tools, 5S (five s), Six Sigma, as required
- Bachelor’s Degree in Engineering
- 7+ years minimum experience within the medical device or electronic manufacturing industry is required.
- Supervisory experience with operators and/or technicians is highly preferred. Thorough and updated knowledge in Engineering principles, concepts, theories and practices.
- Read and analyze pneumatic, hydraulic, and mechanical schematics.
- Troubleshoot electromechanical equipment, and pneumatic, hydraulic, electrical and electronic components of production machines and systems, as well as boiler, autoclave, and/or HVAC system operations
- Upgrade and modify electromechanical and electronics equipment.
- Read and understand operational manuals and troubleshooting guides in order to correct electromechanical equipment failure.
- Operate Programmable Logic Controller (PLCs) software.
- Use, maintain, and store hand and precision tools, shop tools and mechanical equipment.
- Experience with PLC programming & troubleshooting, modify existing ladder logic.
- Experience using Infinity QS is desirable.
- Knowledge and exposure to applicable cGMP’s, FDA Regulations, CAPA’s, Non-Conformances and EHS regulations.
- Must have hands-on experience leading Total Preventive Maintenance (including TPM projects).
- Understanding of Lean Manufacturing and Six Sigma concepts (Green or Black Belt are considered a plus)
- Fully Bilingual (Spanish / English), good communication skills
- Proficient in SolidWorks, Microsoft Office (Word, Excel, Access, PowerPoint).
- Must be able to work under pressure, manage multiple tasks and responsibilities in an effective manner.
- Anticipates and systematically analyzes problems, opportunities, and situations. Must be able to apply sound technical judgment in a timely manner.
- Adhere to company’s Environmental Health and Safety and Quality guidelines as they relate to the manufacturing floor operations and clean room medical device manufacturing
- Must be able to work with minimum supervision and with other departments; by following detailed maintenance instructions
- Exhibits the following competencies: Competencies: Project and Priority Management skills, Results Oriented, Effective Problem Solving skills with significant level of complexity, Effective & Timely Decision making skills, Interpersonal & Communication Skills, Technical Writing Skill