Senior Medical Device Manufacturing Engineer (Onsite)

ProQuality Network; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

ProQuality Network seeks a Senior Manufacturing Engineer to lead initiatives in a regulated medical device environment. The role requires a Bachelor's in Engineering and 5–7+ years in Manufacturing/Process/Validation/Quality Engineering, with expertise in DOE, FMEA, CAPA and GMP.

You will provide technical leadership for process validation, equipment qualification, and continuous improvement, coordinating across Manufacturing, Quality, R&D, Regulatory Affairs, and Supply Chain, on an onsite

Qualifications

• Bachelor's degree in Engineering with 5–7+ years in manufacturing environments.
• Experience with FDA-regulated operations, 21 CFR Part 820, GMP, ISO 13485.
• Knowledge of DOE, FMEA/PFMEA, CAPA, SPC and MSA required.

Responsibilities

• Lead IQ/OQ/PQ and PPQ activities with validation plans and reports.
• Design in-process and inspection systems, control and sampling plans.
• Develop equipment docs, PM, calibration, and WIs.
• Drive Lean and Six Sigma projects to improve yield and cycle time.
• Mentor engineers and coordinate cross-functional teams.

Skills

Manufacturing Engineering

Process Engineering

Validation Engineering

Quality Engineering

LEAN Manufacturing

Project Leadership

Education

Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering

Tools

Minitab

JMP

Job description

ProQuality Network seeks a Senior Manufacturing Engineer to lead initiatives in a regulated medical device environment. The role requires a Bachelor's in Engineering and 5–7+ years in Manufacturing/Process/Validation/Quality Engineering, with expertise in DOE, FMEA, CAPA and GMP.

You will provide technical leadership for process validation, equipment qualification, and continuous improvement, coordinating across Manufacturing, Quality, R&D, Regulatory Affairs, and Supply Chain, on an onsite