We are a global medical device manufacturer that produces a full line of high quality intraocular lenses (IOL’s) and ophthalmic surgical products for cataract and refractive surgery. We are an established medical device manufacturing company looking for experienced, highly motivated individuals to support the growth initiatives and demands. Within Engineering/Manufacturing environment we are seeking the following skillsets;
The Manufacturing Engineer ensures the existence of an effective Manufacturing Maintenance program to ensure that all manufacturing related equipment operates at an optimum level with minimal downtime. Using a hands-on approach, this position ensures that there is technical support for all production equipment/areas.
Some of the essential duties/responsibilities of the position include the following;
- Responsible for all equipment repairs within in the operations area. This includes the design, installation, or troubleshooting of production related equipment.
- Works closely with operations, quality personnel and department heads to facilitate production, process troubleshooting, and equipment maintenance.
- Responsible for effective execution of the Maintenance Schedule, the Preventative Maintenance program and the proper functioning of all production equipment.
- Minimizes production stops due to technical failures and applies a continuous improvement approach toward improvement and the prevention of issues.
- Monitors down time of equipment and systems, sets targets/metrics to reduce occurrences. Ensures the attainment of production goals and targets.
- Prepares and presents reports summarizing information or trends related to manufacturing performance. This involves trend/metrics reporting related to: Downtime,issues trending, time utilization, process, productivity and equipment performance, spare parts utilization and cost reduction initiatives.
- Determines root causes of failures. Identifies opportunities for improvement and recommends changes in equipment design, tolerances, or processing methods.
- When necessary, updates and/or creates/provides input for needed documentation in order to ensure consistent, safe and efficient production: Includes: SOP’s, development of process parameters, inspection instructions, specifications, forms, drawings, etc.
- Effectively writes routine, detailed reports, DOE’s, studies, qualifications and professional correspondence when needed.
- Works to develop and perform optimization measures for manufacturing processes, equipment and software to continuously optimize manufacturing capacity, yield rate, productivity and cost-effectiveness.
- Researches, recommends and purchases required equipment, materials, or parts. E.O.L. identification and participates in future state planning (equipment, layout, etc.).
- Maintains close visibility on departmental budgeting requirements tolls and spare part inventory levels.
- Continuously works to integrate company objectives for safety, quality, reliability and into all equipment maintenance and improvement activities.
- Responsible for safety program for servicing equipment (LOTO, Tagging, etc.). Driving the effective application of documentation of issues, approvals and releases of locked down equipment.
- Must have knowledge of working in U.S. and foreign medical device regulated (GMP, FDA, QSR’s, ISO 13485, CE Mark, ANSI, etc.) environments.
- Seeks future state and innovative approaches for production (processes, floor layout, equipment, etc.) relating to Lean Initiatives, Kaizen, order and cleanliness objectives (5S)
- Understands all applicable processes, equipment and process control technologies.
Qualification / Experience:
The successful Manufacturing Engineer must be able to perform each essential duty with a high level of accuracy and professionalism.
1. Comfortable to work in a high volume fast paced environment.
2. Clean room experience and experience in the ophthalmic industry is a plus.
3. 3+ years of experience in medical devices or ophthalmic industry.
4. Hands on experience and technical knowledge of CNC, Lathes and Milling equipment is a plus.
5. Electromechanical knowledge a plus.
6. BS Mechanical Engineering degree desired.
7. Experience with Lean, 5S, Safety principles desired.
8. Capable of critical thinking, long term system planning, project management skills, and the ability to be pro-active.
9. Must be able to function autonomously, takes initiative and sees all assignments through from 'cradle to grave'.
10. Must be able to manage own time and the time of others effectively.
11. Ability to work well with other departments for support, direction, improvement efforts, etc.
12. Must be able to interface with vendors on specific issues.
13. Ability to communicate, guide and teach requirements, updates, etc. in written and verbal formats as appropriate for the needs of the audience.
14. Knowledge of design techniques, tools, and principals involved in production of precision technical plans, blueprints, drawings, and models.
Our company offers a great benefit package that includes medical, dental, vision, life insurance, 401k with a match. Moreover, we offer our employees the opportunity to work in a challenging new technology and to be part of a strong and talented team who enable healthcare professionals worldwide to improve the lives of their patients in ophthalmology.