**SUMMARY OF POSITION**
This position supports the manufacturing operation under the direction of the Production Superintendent. The senior manufacturing engineer is primarily responsible for leading/supporting multiple projects, process equipment maintenance and acting as the technical resource to the area Manufacturing (Factory) Manager. Interface with marketing to provide product and process capability information, and with production personnel to actively troubleshoot production problems as well as continually improve the process.
**ESSENTIAL FUNCTIONS**
- Responsible for seeing that all tasks are performed in a manner that complies with the Quality Management System the Environmental Management System, and all governing regulatory bodies.
- As a leader and a salaried representative of the Management Team you are expected to be a role model in exhibiting the behaviors and fostering the development of Integrity, Excellence, Teamwork, and Accountability.
- Act as functional owner of all released assembly equipment and software, this includes documentation, calibration, preventative maintenance, stoppages, and utilization, ensuring compatibility between process capability and finished product specifications.
- Ensure compliance with Safety, Environmental and Quality Assurance Programs, eliminate potential ergonomic problems, Waste Reduction, Work Reduction, Safety Projects.
- Identify and understand safety concerns and ensure they are not introduced to the production floor.
- Ability to work flexible hours as project needs dictate.
- Occasional travel (less than 10%) to other manufacturing locations training facilities.
- Other duties as assigned with or without accommodation.
- Trouble shooting of manufacturing processes.
- Six Sigma Projects.
- Process Maps, Cause & Effects Matrix (C&E), Failure Mode and Effects Analysis (FMEA).
- Statistical Process Control (SPC) and Statistical Analysis using Minitab.
- Lean Manufacturing Projects.
- Kaizen Events, Kanban, Poka-Yoke.
- Waste Reduction, Work Reduction.
- Safety Projects.
- Validation Projects. IQ, OQ, PQ, and Test Method validation protocols and reports.
- General understanding of ISO and FDA requirements and sample plans.
- Customer Complaints.
- Address customer complaints and determine root cause and potential solutions.
- Root Cause Analysis to determine potential solutions based on risk, cost, and time.
- Writes and Executes Trials to test new materials and new concepts.
- Technical resource to supervisors, operators, and technicians in regard to machines, process, test equipment, and general manufacturing techniques.
- Identify machine/equipment improvements and latest market technology.
- Write Capital Expenditure Request (CERs) to obtain capital for various types of projects Interface with R&D and marketing to develop new products.
- Writes and/or updates all documentation used on the production floor in the manufacturing of product, including process SPIs, general SPIs, and lab SPIs.
- Other duties assigned with or without accommodation.
**RESPONSABILITIES AND ROLES EHS**
**Responsibilities**
- Comply with statutory responsibility under the national or federal regulations such as taking reasonable care of his or her own safety, health and welfare and of any other persons who may be affected by his or her acts or omissions at work
- Follow established EHS procedures and policies
- Encourage coworkers to follow EHS procedures
- Participate in employee engagement activities such as EHS inspections and EHS meetings
- Report EHS incidents and hazards, assist in root cause analysis as appropriate, and cooperate in finding solutions or implementing improvement
- Complete required EHS training
**Roles**
- Require the use of Personal Protective Equipment
- Stop work in the event of contractors or other employees performing work that may lead to a serious injury or environmental incident
- Refuse to carry out an activity that jeopardizes the health of your own or staff and the building or facilities.
- Refuse to perform operations/activities in which you are not trained or feel that your integrity is at risk.
**REQUIREMENTS**
- Bachelor's degree in Chemistry, Engineering, or related scientific field is required.
- Minimum three years manufacturing experience on medical devices or similar regulated manufacturing environment.
**_ Preferred Qualifications_**
- Machine validation experience in medical industry.
- Expert user of Microsoft Office tools (Word, Excel, PowerPoint, Project, Access).
- Minitab, Lean and Six Sigma tools and implementation techniques.
- Working knowledge of Cost reduction and quality improvement in production processes.
- Six sigma Green Belt Certification.
- Project Management skills.
- Working knowledge of quality system regulations, GMPs and ISO requirements.
- An intermediate English level (B2 level - ECFR).
- Excellent written and oral communication skills.
- Adaptability.
- Problem resolution.
- Focus on results.
- Car
