Job Description
Job Description
Job Description
We are seeking an experienced CNC Machinist with a strong background in medical device manufacturing to join our growing team. This role is responsible for independently setting up, operating, troubleshooting, and optimizing CNC equipment used to manufacture highly complex and precision medical components. The ideal candidate possesses extensive experience working in regulated manufacturing environments and demonstrates expertise in CNC machining, inspection methodologies, process control, and quality compliance.
This position plays a critical role in ensuring products consistently meet stringent customer specifications, dimensional tolerances, and regulatory requirements while supporting operational excellence and continuous improvement initiatives.
Key Responsibilities
- Independently set up, operate, and troubleshoot CNC lathes, mills, Swiss machines, grinders, and other precision machining equipment used in the manufacture of medical devices.
- Perform machine changeovers, tooling setups, offset adjustments, program verification, and first-piece inspections.
- Interpret engineering drawings, GD&T requirements, work instructions, routers, and manufacturing specifications.
- Monitor machining processes and make necessary adjustments to maintain dimensional accuracy, surface finish, and process capability.
- Investigate and resolve machining, tooling, programming, and quality-related issues to minimize downtime and improve efficiency.
- Perform in-process, first-article, and final inspections using precision measuring instruments and visual inspection equipment.
- Utilize micrometers, calipers, bore gauges, height gauges, optical comparators, vision systems, microscopes, and other inspection technologies to verify product conformance.
- Document inspection results, nonconformances, and production records while maintaining complete traceability requirements.
- Collaborate with Quality, Engineering, Manufacturing, and Continuous Improvement teams to optimize production processes.
- Support validation activities, process qualifications, and continuous improvement projects focused on quality, throughput, and cost reduction.
- Maintain compliance with all company safety requirements, quality system procedures, and regulatory standards.
- Participate in root cause investigations and corrective and preventive action (CAPA) activities.
- Maintain a clean, organized, and audit-ready work environment utilizing 5S and Lean Manufacturing principles.
- Train and mentor junior machinists and operators as needed.
Required Qualifications
- High School Diploma or GED required.
- Technical degree, machining certification, or apprenticeship preferred.
- Minimum 5 years of CNC machining experience, preferably within the medical device, aerospace, or other high-precision manufacturing industries.
- Demonstrated experience with CNC setup, operation, troubleshooting, and process optimization.
- Strong understanding of cutting tools, speeds and feeds, workholding, tooling selection, and machining principles.
- Experience working with stainless steel, titanium, cobalt chrome, Nitinol, and other medical-grade materials preferred.
- Ability to read and interpret complex engineering drawings and GD&T.
- Strong mechanical aptitude and analytical problem-solving skills.
Quality & Regulatory Experience
Candidates must have experience working within regulated manufacturing environments and demonstrated knowledge of:
- FDA 21 CFR Part 820 and current Quality Management System requirements.
- ISO 13485 Medical Device Quality Management Systems.
- Good Documentation Practices (GDP).
- Good Manufacturing Practices (GMP).
- Device History Records (DHR).
- Traceability and product identification requirements.
- Nonconformance reporting and CAPA processes.
- Internal, customer, and regulatory audit readiness.
Technical Skills
- CNC machine setup and operation.
- Tool offset management and machine calibration.
- Blueprint reading and GD&T interpretation.
- Statistical process control (SPC).
- Precision dimensional inspection techniques.
- Vision inspection systems and optical measurement equipment.
- Micrometers, calipers, dial indicators, bore gauges, thread gauges, and comparator systems.
- Root cause analysis and troubleshooting methodologies.
- ERP and electronic manufacturing record systems experience preferred.
Preferred Qualifications
- Experience with Swiss machining, Rollomatic grinders, CNC milling, or CNC turning centers.
- Medical device manufacturing experience producing implants, surgical instruments, guidewires, orthopedic, trauma, spinal, or cardiovascular components.
- Lean Manufacturing and Six Sigma experience.
- Prior experience supporting FDA, ISO, or customer audits.
What Makes You Successful
- Commitment to producing defect-free products.
- Exceptional attention to detail and precision.
- Strong sense of accountability and ownership.
- Ability to work independently and in a collaborative team environment.
- Continuous improvement mindset.
- Passion for manufacturing products that improve patient lives.
Physical Requirements
- Ability to stand and walk for extended periods during a 10-12 hour shift.
- Ability to frequently lift and move materials weighing up to 50 pounds.
- Ability to perform close visual inspections using microscopes, optical equipment, and precision measuring devices.
- Ability to safely work around moving machinery and utilize required PPE.