Med Device Manufacturing Engineer – Process Innovator

SaintsReport; Jackson (MS); Hybrid; USD 65,000 - 90,000; Full time

Job summary

SaintsReport.com in Jackson, MS is seeking a Manufacturing Engineer to apply deep knowledge of medical device manufacturing. You will collaborate with production and quality teams to optimize processes and ensure product conformity.

Responsibilities include developing production processes, performing R&D on flow, machining and assembly, applying statistical methods and Qb checks, executing time studies, and supporting ISO 13485 and FDA 21 CFR Part 820 certifications.

Qualifications

• BS degree in mechanical engineering is preferred.
• Five to ten years of experience in ISO 13485 and FDA 21 CFR 820 environments.
• Experience working in cross-functional project teams.

Responsibilities

• Act as the Manufacturing representative design and development of production processes including: quality control, inventory control, material and logistics flow, cost analysis.
• Perform R&D on manufacturing processes including: p-flow, machining and assembly methods, production equipment
• Apply statistical methods to characterize, baseline and improve manufacturing processes from a quality and cost perspective; participate in design and process FMEA’s and Risk Analysis activities
• Ensure that product conformance is met through product development and manufacturing to meet customer satisfaction
• Perform time studies for establishing process standards and efficiencies and make improvements. Identify, prioritize and communicate process improvement opportunities
• Review and approve engineering protocols and reports
• Participate in activities to obtain ISO certifications

Skills

Strong communication

Six Sigma

FMEA

Root Cause Analysis

DOE

MS Excel

MS Word

MS Project

Minitab

Education

Bachelor's degree in Mechanical Engineering

Tools

Minitab

MS Project

Job description

SaintsReport.com in Jackson, MS is seeking a Manufacturing Engineer to apply deep knowledge of medical device manufacturing. You will collaborate with production and quality teams to optimize processes and ensure product conformity.

Responsibilities include developing production processes, performing R&D on flow, machining and assembly, applying statistical methods and Qb checks, executing time studies, and supporting ISO 13485 and FDA 21 CFR Part 820 certifications.