TRC Professional Solutions, on behalf of the Client, is hiring for a Manufacturing Engineer for contract to hire (after 3 months) opportunity in the greater Atlanta area,
The Manufacturing Engineer is responsible for meeting internal customer manufacturing requirements for high-end products through robust process design. The Manufacturing Engineer will design, develop and implement manufacturing processes, tooling and fixtures in a regulated 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.
About TRC Professional Solutions
For over 10 years, professionals and employers have trusted TRC Professional Solutions with their business and careers. Year after year, Inavero’s Best of Talent and Staffing awards have been presented to TRC Professional Solutions for providing superior service and results to both our clients and job seekers. We create a different experience for our candidates and clients by remaining solely focused on bringing the right talent to the right opportunity, throughout every stage of our unique recruitment process. For more information, visit: https://www.trcprofessionalsolutions.com/