Manufacturing Engineer I Job at Medical Murray in Charlotte

Position Title: Manufacturing Engineer (all levels)

Location: Charlotte, NC

Are you passionate about engineering and making a difference in the medical device industry? We are seeking a Manufacturing Engineer to join our team in Charlotte, NC. In this role, you’ll drive process improvements, manage product transitions from development to production, and ensure the highest standards of quality and compliance.

The Manufacturing Engineering position performs equipment and process transfer from product development to production as well as improvements in equipment, tooling, and processes for ongoing production in the production department in support of the production department objectives to provide goods and services that meet customer’s requirements for quality quantity, and timeliness. The position will take on multiple projects of high complexity and provide mentoring, direction, and management on the day-to-day activities of the manufacturing engineering staff.

Job Responsibilities

• Support facility’s Quality System and tactical plans.
• Design, develop, qualify and validate manufacturing processes and tooling/equipment.
• Drive continuous improvement, improved safety and cost reductions utilizing Value Stream Mapping, 5S, and other relevant lean manufacturing tools.
• Statistically analyze data (e.g., process capability, Design of Experiments).
• Trouble-shoot processes, equipment and quality systems and develop/implement corrective and preventive actions.
• Support transfer of products into production after completion of transfer design review.
• Effectively train employees on manufacturing specifications and processes.
• Manage process validation following master validation plans after completion of transfer design review - including IQ, OQ, PQ, gauge R&R, and software validation.
• Support annual risk analysis and manage DMR updates.
• Provide sound engineering judgement and decisions.
• Perform other duties as assigned.

Qualifications

• Capable of translating technical documents to production personnel.
• Ability to be flexible and deal with changing priorities.
• High energy level, attention to detail, and a sense of urgency.
• Demonstrates strong communication skills across all levels of the organization (internal and external).
• Customer focus, innovative, results oriented.
• Take the initiative in learning new technologies and materials.
• Computer skills including MS Office, SolidWorks, or alternative CAD program

Experience

• 0-10+ years of experience with manufacturing and process engineering, medical device manufacturing preferred.
• ISO experience, cGMP and ISO 13485 preferred.
• Previous Coop/Internship experience in a FDA regulated environment preferred.
• Knowledge in line balancing, capacity analysis, ergonomic risk analysis, time studies and statistical process control preferred
• Experience in a regulated environment preferred
• Six Sigma Certification preferred

Education

Medical Murray is an Equal Opportunity Employer.