Senior Manufacturing Engineer

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

Title: Senior Manufacturing Engineer (Medical Devices)

Work Schedule: Onsite

Contract Duration: 6 to 12 Months

Position Overview

Our client is seeking an experienced Senior Manufacturing Engineer to lead manufacturing engineering initiatives within a regulated medical device manufacturing environment. This role is ideal for candidates with a Bachelor's degree in Engineering and 5 to 7+ years of experience in Manufacturing Engineering, Process Engineering, Validation Engineering, or Quality Engineering supporting FDA-regulated operations.

The selected candidate will provide technical leadership for manufacturing operations, process validation, process optimization, equipment qualification, documentation, and continuous improvement initiatives while collaborating with cross-functional teams throughout the product lifecycle.

Minimum Qualifications

• Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or a related Engineering discipline.
• 5 to 7+ years of experience in Manufacturing Engineering, Process Engineering, Validation Engineering, or Quality Engineering within an FDA-regulated manufacturing environment.
• Strong knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices required in regulated manufacturing environments.
• Experience applying electrical and mechanical engineering principles to automated or semi-automated manufacturing systems.
• Hands-on experience with automation and controls, tooling, fixtures, test method development, equipment qualification, and manufacturing process validation.
• Working knowledge of Design of Experiments (DOE), FMEA/PFMEA, CAPA, Root Cause Analysis, Statistical Process Control (SPC), Measurement System Analysis (MSA), and process capability tools.
• Experience using statistical software such as Minitab, JMP, or equivalent.
• Experience leading or participating in Lean Manufacturing, Six Sigma, Kaizen, Value Stream Mapping, or other continuous improvement methodologies is preferred.
• Experience supporting product introduction, process scale-up, design transfer, and manufacturing process improvements.
• Strong project management, technical writing, analytical thinking, communication, and cross-functional leadership skills.

Key Responsibilities

• Lead IQ/OQ/PQ and Process Performance Qualification (PPQ) activities, including the development of validation protocols, reports, and Master Validation Plans.
• Design and develop in-process and receiving inspection systems, control plans, sampling plans, and inspection methods for manufacturing processes and components.
• Generate, review, and approve equipment documentation, preventive maintenance and calibration procedures, manufacturing work instructions, and process control documentation.
• Lead manufacturing projects from concept through implementation while coordinating activities across Manufacturing, Quality, Research & Development, Regulatory Affairs, Supply Chain, and external suppliers.
• Apply Design of Experiments (DOE), PFMEA, risk assessments, Statistical Process Control (SPC), Measurement System Analysis (MSA), and Root Cause Analysis methodologies to optimize manufacturing processes and improve product quality.
• Drive Lean Manufacturing and continuous improvement initiatives to increase process capability, improve yield, reduce cycle time, enhance throughput, lower manufacturing costs, and improve equipment performance.
• Provide technical leadership for manufacturing technologies, including laser welding, heat bonding, injection molding, automation systems, vision systems, tooling, fixtures, test methods, and equipment qualification activities.
• Lead or participate in manufacturing process validation, equipment qualification, technology implementation, and process optimization projects.
• Manage Change Control activities, CAPA implementation, nonconformance investigations, and product and process scale-up while ensuring compliance with site Quality Systems and regulatory requirements.
• Mentor junior engineers and provide technical guidance to project teams while operating with a high degree of independence.

Quality Expectations

• Demonstrate a strong commitment to patient safety, product quality, and regulatory compliance by adhering to all applicable quality procedures.
• Maintain accurate and compliant documentation while promoting Quality System requirements and documentation discipline.
• Provide technical guidance to cross-functional teams to ensure compliance with internal procedures, regulatory expectations, and quality standards.