Lead Manufacturing Engineer, Medical Devices & Validation

Fractyl Health, Inc; Burlington (MA); On-site; USD 115,000 - 165,000; Full time

Job summary

A leading medical device company in Massachusetts is seeking a Principal Manufacturing Engineer responsible for defining, validating, and sustaining manufacturing processes for electromechanical medical devices. The role includes leading manufacturing strategies, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. Candidates should have a Bachelor's degree and at least 10 years of manufacturing engineering experience, preferably in the medical device field. The position offers a competitive salary ranging from $115,000 to $165,000 annually, along with comprehensive benefits.

Qualifications

• Minimum of 10 years of manufacturing engineering experience in a regulated environment.
• Medical device experience preferred (ISO 13485, ISO 14971).

Responsibilities

• Lead development and execution of manufacturing, test, and validation strategies.
• Serve as a technical authority for manufacturing process development.
• Develop and maintain Master Validation Plans (MVPs).
• Ensure all validation activities comply with FDA and ISO standards.
• Analyze data trends to establish control strategies.

Skills

Expertise in electromechanical manufacturing processes

Strong statistical analysis and validation experience

Knowledge of regulatory requirements for medical devices

Experience with SolidWorks

Familiarity with schematic tools

Experience with single-use device processes

Strong technical writing and documentation skills

Ability to manage projects and work cross-functionally

Education

Bachelor’s degree in Mechanical, Electrical, Manufacturing, Biomedical Engineering, or related field

Tools

SolidWorks

Minitab

Job description

A leading medical device company in Massachusetts is seeking a Principal Manufacturing Engineer responsible for defining, validating, and sustaining manufacturing processes for electromechanical medical devices. The role includes leading manufacturing strategies, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. Candidates should have a Bachelor's degree and at least 10 years of manufacturing engineering experience, preferably in the medical device field. The position offers a competitive salary ranging from $115,000 to $165,000 annually, along with comprehensive benefits.