CTL Amedica is an ISO 13485 certified and FDA registered Medical Device Company with offices in Addison, Texas. CTL designs, manufactures and distributes medical device products and systems for spinal surgeons; specifically implants and devices.
The Senior Manufacturing Engineer leads internal/supplier process development and validation activities required to ensure reliable production of medical device products. This position ensures all products are manufactured in compliance with established product specifications per internal procedures, cGMP CFR 820 and ISO 13485:2016 requirements. The Senior Manufacturing Engineer will support company projects to improve product quality, productivity and reduce cost with a strong emphasis on utilization of Lean Manufacturing.
DUTIES AND RESPONSIBILITIES:
- Participates in cross functional New Product Development projects to provide manufacturing related design control deliverables and ensure compliant and timely transition of new products to commercialization.
- Responsible for internal manufacturing equipment selection, qualification (IQ/OQ/PQ) and process validation activities and associated documentation.
- Works closely with suppliers, purchasing and development to ensure design and process requirements are adequately defined and understood by suppliers.
- Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
- Develops and implements process workflow routers and bill of materials per applicable device master record.
- Develops/Documents process risk management plans and ongoing maintenance.
- Prepares and presents return on investment proposals (ROI) for management review, regarding anticipated equipment purchases, process improvements and/or product quality improvements.
- Reviews design changes for drawing accuracy, and impact to manufacturing processes.
- Generates and implements Engineering Change Orders.
- Supports manufacturing/suppliers by developing shop aides/fixtures, manufacturing procedures, drawings & specification interpretation.
- Participates in product post market and continuous improvement activities.
ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS:
- Bachelor’s Degree, in Mechanical or Industrial Engineering
- Minimum 5 years prior Manufacturing Engineering or similar experience in a medical device or pharmaceutical environment.
- Intermediate-Advanced skill with PTC Creo or similar 3D CAD software
- Experience in the application of statistical techniques such as statistical process control, design of experiments, and problem-solving techniques.
- Lean Six Sigma Green Belt or higher.
- Working knowledge of Microsoft applications including MS Project.
- Strong problem solving skills.
- Solid project management skills-able to handle multiple tasks simultaneously.
- Solution driven and professional.
NONESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred):
- CNC Swiss programming via Partmaker or similar application.
- Experience utilizing advanced mills/ lathes
- Machine tooling design
- Familiarity with ERP Systems
****This is a full-time position, benefits available 401K with employer matching, great health plan, dental and vision and paid sick days, holidays and vacation****
IF YOU WANT TO APPLY OR HAVE FURTHER QUESTIONS,
PLEASE SEE HR