The Manufacturing Development Engineer is the lead manufacturing point person for mechanical and system design, analysis and improvement of automation equipment driving quality and productivity improvements.
The Manufacturing Development Engineer has responsibility for designing, setting up, optimizing and monitoring the manufacturing process and supports Paragon's long-term goal of automation the production process and develop continues improvement culture at the Gilbert and Mesa Arizona sites.
- Lead and support Automation projects to improve quality, cost and capacity with demonstrated skills in project management and technical problem solving.
- Define, prioritize and implement improvement projects aligned with Key Performance Indicators, OEE improvement and long term business objectives.
- Apply and champion effective and efficient problem solving and statistical tools to implement robust solutions that are verified and validated for medical device manufacturing.
- Design and develop mechanical and automation solutions working closely with controls/process engineers and other functional areas.
- Identify potential new technologies for possible application to production and development activities.
- Prepare and conduct protocols to validate improvements on manufacturing equipment and processes.
- Support capacity expansion projects including requirements, development, technical reviews, FAT and IQ/OQ/PQ.
- Provides technical support and development of maintenance and automation technicians including 24/7 engineering support as required.
- Complete both specialized and broad-based assignments / projects which may require collaboration and integration with other functions.
- Assist Manufacturing personnel in process troubleshooting and improvements.
- Train employees on new technologies and manufacturing processes.
- Write, prepare, and generate technical reports.
Paragon's management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.
KNOWLEDGE, SKILLS AND ABILITIES
- Self-motivated and internally driven with ability to work independently.
- Process technologies including precision part handling, assembly, vision inspection, laser marking, robotics.
- Demonstrated experience with pneumatic and integrated motion systems.
- Demonstrated success in structured problem solving.
- Fundamental knowledge in Lean Manufacturing, Six Sigma, Quick Changeover, Error Proofing.
- Understanding of manufacturing metrics as they align to Process Improvement initiatives.
- Knowledge in process design and development, PFD/PFMEA, error proofing, statistical process control and monitoring.
- Ability to define project objectives, create and execute project plans.
- AutoCAD and SolidWorks proficiency.
- Ability to effectively present information and respond to questions from managers, customers, and government regulatory officials.
- Ability of self-learning and natural curiosity.
- Team-oriented focus with an ability to find innovative technical solutions.
- Demonstrated engineering and design skills (CAD).
- Careful attention to detail to ensure accurate and precise execution of work tasks and procedures.
- Intermediate skill in the use of Excel, Word and PowerPoint. Advanced preferred.
- Will often work near moving mechanical parts.
- Travel may be required.
- There will be extended periods of sitting and using a computer.
- The noise level in some of the work environments can be unusually loud and require hearing protection.
- Potential exposure to caustic chemicals.
- B.S. in Mechanical Engineering or closely related engineering discipline; or an equivalent combination of education and experience.
- Lean Six Sigma certification preferred.
- Minimum of 7-10 years' experience with progressive assignments in automated machine development, qualification and continuous improvement in a manufacturing environment.
- Experience in medical device manufacturing environments a plus.