TRC Professional Solutions, on behalf of the Client, is hiring for a Manufacturing Engineer (Advanced Level) – Machine Validations for a contract role (90 days) in the Greater Atlanta area.
The Manufacturing Engineer is responsible for meeting internal customer manufacturing requirements for spinal implants through robust process design. The Manufacturing Engineer will design, develop and implement manufacturing processes, tooling and fixtures in a regulated medical device environment, to meet daily production schedules and project needs while enhancing productivity and product quality.
- Define, develop and document test, manufacturing and quality processes and tooling and generate associated documentation to facilitate manufacturing of products in accordance with FDA, QSR, and ISO requirements and company policy.
- Establish processes and specify related equipment and fixtures.
- Document manufacturing processes and work instructions in conjunction with engineering.
- Provide disposition of non-conforming parts, identify root cause, and implement corrective and/or preventive action to reduce scrap and rework.
- Collaborate with design engineering during prototype, development and first article manufacturing. Ensure the inclusion of appropriate quality and manufacturing requirements.
- Requires experience with drawings and BOMs; work instructions; engineering change systems; quality systems for non-conforming parts and corrective action.
- Coordinate activities associated with "first article build" of new products, ensuring that fabricated items are traceable to documented standards at the time of release of product.
- Full understanding and demonstrated knowledge of engineering principles. Ability to read and understand engineering drawings and specifications.
- Establish and conduct process qualifications and validations, and contribute to the process portion of project schedules.
- May provide direction for, supervise and/or train Manufacturing or Production personnel.
- Contributes towards ensuring projects adhere to established Design Control system.
- Responsible for solving component or processes issues while sustaining process flow and throughput.
- Supports project planning and timeline execution.
- Supports Device Master Record (DMR) development.
- Responsible for the process flow development including value stream mapping, process and product characteristics, and CTQ flow through.
- Supports pFEMA development and team discussions along with managing the risk mitigation activities and testing.
- Supports Control Plan (CP) development including inspection methodology, prevention controls, detection controls, reaction plans, inspection frequency rationale, and ongoing monitoring.
- Supports supply chain development.
- Supports post production meetings.
- Participates in quality and regulatory audits.
- Assists in project tracking and metric development to monitor ongoing performance.
- Creates operator work instructions to communicate process knowledge.
- Works proactively with the team to share best-practices and lessons learned.
- Fosters close and productive relationships with cross-functional counterparts.
- Understands project schedules for all manufacturing projects.
Education and Experience
- Bachelor’s Degree in Mechanical Engineering; 3+ years Medical Device experience required.
- Minimum three years of experience or educational background, with tight tolerance methods in machining and measurement system applications, blueprint reading, GD&T, working knowledge of short run process control methods, statistical analysis, DOE, ISO standards and FDA quality system regulations.
- Excellent interpersonal and communication skills.
- Able to work with minimal supervision and actively participate in a team oriented, continuous improvement, manufacturing environment.
- Working knowledge of measuring equipment and tools typically used in a manufacturing environment (e.g., CMM, Optical measurement systems, etc.)
- High level knowledge of statistical analysis concepts and software.
- Superior organizational skills and attention to detail required.
- Strong leadership, ability to handle multiple tasks and prioritize in a fast-paced environment.
- Strong problem-solving, decision-making, and process improvement skills. Windows-based computer knowledge required and working experience with CAD / CAM systems preferred.
- Experience with SolidWorks is preferred
- The ability to use computer and machine shop equipment
This position requires no travel