Onsite Manufacturing Engineer – Medical Devices

Nuclein,-LL; Austin (TX); On-site; USD 70,000 - 95,000; Full time

Job summary

Nuclein,-LL in Austin, TX is seeking a Manufacturing Engineer to provide technical support for cGMP manufacturing operations. This role focuses on instrument and cartridge production and interfaces with QA, Production, Supply Chain, Engineering and Assay Development to ensure on-time delivery of high-quality devices for company growth.

You will lead validations, test equipment design, process development, and automation efforts; develop manufacturing instructions and training for direct labor;

Qualifications

• Bachelor's degree in a relevant field.
• 3+ years of manufacturing engineering experience in medical devices, instrument manufacturing preferred.
• Experience with FDA CFR820 and ISO13485-2016 is desirable.
• Strong problem-solving, decision-making and collaboration skills.
• Detail-oriented with ability to prioritize and work independently.

Responsibilities

• Lead manufacturing engineering activities including validations, test equipment design, and process development.
• Implement automation equipment and tooling for manufacturing.
• Collaborate with QA, production, supply chain, engineering and assay development.
• Drive continuous improvement and cost reductions in manufacturing.
• Develop manufacturing instructions and training for direct labor.
• Ensure compliance with GMP and FDA regulations and participate in audits.
• Support 3rd party compliance audits and MRB processes.
• Maintain BOMs, routings and process documentation.
• Provide technical support for design for manufacturability and product changes.

Skills

Problem solving

Collaboration

Attention to detail

Communication

Independent working

Education

Bachelor's degree

Job description

Nuclein,-LL in Austin, TX is seeking a Manufacturing Engineer to provide technical support for cGMP manufacturing operations. This role focuses on instrument and cartridge production and interfaces with QA, Production, Supply Chain, Engineering and Assay Development to ensure on-time delivery of high-quality devices for company growth.

You will lead validations, test equipment design, process development, and automation efforts; develop manufacturing instructions and training for direct labor;