Starting Wage : $80,000+ per year DOE
SUMMARY
We are seeking a dedicated and innovative Manufacturing Engineer to enhance and optimize processes within our medical device manufacturing department. Your primary focus will be to collaborate with the Quality team to ensure compliance with ISO 13485 standards, facilitate the onboarding of new business, and manage Bill of Materials (BOMs) and Routings in our ERP system for new product introductions and process modifications. You will play a crucial role in promoting safety, housekeeping, and continuous improvement initiatives within the facility.
REQUIREMENTS / EDUCATION and / or EXPERIENCE
A College Degree (BS) in an Engineering discipline is required, along with a minimum of 3 years of manufacturing experience in an ISO 13485 regulated environment.
- Experience in a Clean Room environment is essential.
- Hands-on experience with injection molding and extrusion machinery is required.
- Lean Six Sigma training and certification are highly desired.
- Proficiency in MS Office (Outlook, Excel, PowerPoint) is required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Collaborate with Quality to ensure all processes meet ISO 13485 compliance standards.Develop and execute IQ / OQ / PQ validation protocols for new equipment and process changes, and prepare summary reports for management review.Lead root cause analysis for customer complaints and process inefficiencies, ensuring corrective actions are implemented.Assist in creating machine specifications and modifying equipment layouts to optimize process flow.Identify potential equipment upgrades or new requirements and perform cost analyses and justifications for capital requests.Utilize Continuous Improvement tools and Lean Six Sigma methodologies to guide Kaizen events and improvement initiatives.Demonstrate strong project management skills and the ability to multitask effectively while meeting deadlines and customer commitments.Engage with customers on inquiries and oversee new products from concept to prototype to production.Work effectively in a Clean Room environment, applying knowledge of acceptable practices and change management.Exhibit excellent communication skills and a team-oriented mindset.Create part drawings, tool drawings, and 3D models for new parts and assemblies.Monitor and report key production KPIs during daily meetings.Develop work instructions, batch sheets, and process standards for existing and new operations.Assist with the coordination of equipment calibration and the management of preventive and predictive maintenance programs.Regularly review established production methods to discover opportunities for improvement in safety, quality, and productivity.Support special projects as needed.Join us in making a difference in the medical device industry and take the next step in your career!
