GMP Device Engineer: Mechanical Testing & Manufacturing Support

3key Consulting, Inc.; New Albany (OH); On-site; USD 43,000 - 48,000; Part time

Benefits offered by this job

Onsite 5 days/week

Job summary

3key Consulting, Inc. is seeking a Device Engineer for GMP manufacturing support and mechanical testing in New Albany, OH. This contract role involves hands-on engineering in a regulated environment, ensuring quality systems are followed and issues are triaged, tested, and documented.

The ideal candidate has GMP experience, strong documentation skills, and familiarity with mechanical testing tools such as Instron, with CAD/SolidWorks being a plus. Onsite work is required, with potential overtime.

Qualifications

• GMP manufacturing experience and documentation practices.
• Experience with quality systems and ISO standards.
• Strong communication and technical writing.
• Proficiency with Instron testing and measurement methods.

Responsibilities

• Collaborate cross-functionally with SMEs to identify device issues and root causes.
• Expand documentation of site capability and control strategies.
• Ensure expedited communication to the wider team on risks to device manufacturing.
• Authors and reviews protocols, reports, and technical assessments.
• Analyze data using statistical methods to support decisions.
• Coordinate and execute laboratory testing for characterization and design transfer.
• Maintain design history files for assigned products.
• Develop characterization test methods through fixture prototyping and GR&R analysis.
• Provide subject matter expertise in system-level root cause analysis and change controls.
• Provide general lab support including inventory and sample shipments.
• Work with scientists and engineers to develop design/manufacturing specs.
• Represent device engineering within a large matrix organization.

Skills

GMP manufacturing

Instron systems

Technical writing

CAD SolidWorks

Cross-functional teamwork

Education

Engineering degree (Bachelor or higher)

Tools

SolidWorks

Job description

3key Consulting, Inc. is seeking a Device Engineer for GMP manufacturing support and mechanical testing in New Albany, OH. This contract role involves hands-on engineering in a regulated environment, ensuring quality systems are followed and issues are triaged, tested, and documented.

The ideal candidate has GMP experience, strong documentation skills, and familiarity with mechanical testing tools such as Instron, with CAD/SolidWorks being a plus. Onsite work is required, with potential overtime.