Senior MedTech Manufacturing Engineer & Validation

JobDiva, Inc.; Warsaw (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Senior Manufacturing Engineer with a strong background in manufacturing engineering, equipment validation, and medical device manufacturing within a regulated environment.

The role requires hands-on IQ/OQ/PQ validation protocol development, regulatory knowledge (ISO 13485, GMP, 21 CFR Part 820, ISO 14971), and expertise in Master Validation Plans, FMEA, CAPA, and MSA. Proficiency with metrology and eQMS platforms is expected.

Qualifications

• Bachelor's degree in mechanical, manufacturing, biomedical engineering, or related field.
• 5+ years of manufacturing and equipment validation in MedTech/Pharma/Healthcare Devices.
• Strong knowledge of ISO 13485, GMP, 21 CFR Part 820, ISO 14971 risk management.
• Hands-on IQ/OQ/PQ validation protocol development and execution.
• Expertise in Master Validation Plans, FMEA, CAPA, and validation documentation.
• Experience with metrology, calibration, Gauge R&R, and MSA.
• Knowledge of CNC machines, CAM software, and basic CNC programming concepts.
• Experience with statistical tools (Minitab or JMP) for CP studies.
• Familiarity with Document Control and eQMS (MasterControl or ETQ).

Skills

5+ years experience

IQ/OQ/PQ validation

Statistical analysis (Minitab/JMP)

Regulatory knowledge (ISO13485, GMP, U

Education

Bachelor's degree in Mechanical/Manufacturing/Bioengineering

Tools

Master Validation Plans

FMEA

CAPA

Validation documentation

Gauge R&R

MSA

Master Control

ETQ

CNC CAM software basics

CNC programming basics

Job description

Summary:
We are looking for an experienced Sr. Manufacturing Engineer with a strong background in manufacturing engineering, equipment validation, and medical device manufacturing within a regulated environment.

Requirements:

• Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or a related field
• 5+ years of experience in manufacturing and equipment validation (MedTech, Pharma, or Healthcare Devices)
• Strong knowledge of ISO 13485, GMP, 21 CFR Part 820, and ISO 14971 risk management principles
• Hands-on experience developing and executing IQ/OQ/PQ validation protocols
• Expertise in Master Validation Plans, FMEA, CAPA, and validation documentation
• Experience with metrology, calibration, Gauge R&R, and Measurement System Analysis (MSA)
• Knowledge of CNC machines, CAM software, and basic CNC programming concepts
• Experience with statistical analysis tools such as Minitab or JMP for process capability studies
• Familiarity with Document Control and eQMS platforms such as Master Control or ETQ