Lead Medical Device Process Engineer - Validation and Lean

Safeguard Medical; Huntersville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Safeguard Medical is seeking a qualified individual responsible for leading the development and validation of processes used in manufacturing medical devices. This involves working closely with production facilities and vendors throughout the product life cycle to improve manufacturing processes and create necessary documentation.

The ideal candidate will have over 10 years of experience in the medical device or pharmaceutical industry, with a strong foundation in engineering and a proven ability to lead cross-functional teams in achieving manufacturing goals.

Qualifications

• More than 10 years of relevant experience in medical device or pharmaceutical field.
• Experience with process development, qualification, and validation.
• Must fit within the Safeguard Medical culture.

Responsibilities

• Develop and improve manufacturing processes concerning product life cycle.
• Act as a technical liaison for new and existing products.
• Lead process-related risk management activities.

Skills

Process mapping

Problem-solving skills

Team-oriented

3D modeling

LEAN Manufacturing

Six Sigma Methodology

Education

B.S. in Mechanical Engineering or related field

Tools

SolidWorks

Microsoft Office

MiniTab

D365

Job description

Safeguard Medical is seeking a qualified individual responsible for leading the development and validation of processes used in manufacturing medical devices. This involves working closely with production facilities and vendors throughout the product life cycle to improve manufacturing processes and create necessary documentation.

The ideal candidate will have over 10 years of experience in the medical device or pharmaceutical industry, with a strong foundation in engineering and a proven ability to lead cross-functional teams in achieving manufacturing goals.