Manufacturing Engineer (Instrument)

Our client is a dedicated Austin-based, private equity-funded, medical device company that offers an innovative, FDA EUA-authorized, rapid PCR, point-of-care system. Their product is easy to use, affordable, and provides PCR results in only 15 minutes. They have a vision to enable simple, affordable, rapid, and accurate testing for everyone. They are an incredibly talented and diverse team of scientists, engineers, and experienced professionals who are driven to excel and significantly contribute to the world!

As they continue to grow exponentially, they are looking for a Manufacturing Engineer (Instrument) to provide technical support for cGMP manufacturing operations, specifically focusing on instrument production. The role involves direct coordination with various departments to ensure timely delivery of high-quality devices in line with company expansion and supply needs.

What’s in it for YOU? 

• They offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as they work to expand the use of transformative testing technology in the market.
• A wonderful company culture with great core values and looking for team players who also align with them – Value Everyone, Ownership, Innovation, Collaboration, and Excellence Driven! 
• Very exciting time to work with an awesome leadership team that has proven experience commercializing biotech, including expertise in system and assay research and development, regulatory, intellectual property, engineering, and manufacturing. 
• This company is in a growth mode and is bound for great things! This is an opportunity for you to help make a significant difference with this delivery to the world!

What YOU get to DO at this growing company: 

• Lead and manage various manufacturing engineering activities, including validations, test equipment design, process development, and automation implementation.
• Collaborate with Development groups to implement engineering changes and ensure compliance with FDA regulations and GMP guidelines.
• Monitor production metrics and implement corrective actions to improve process efficiency.
• Develop equipment, tools, and processes for manufacturing.
• Resolve CAPAs and product non-conformances, support compliance audits, and provide technical support for design and manufacturing.
• Foster a culture of teamwork, accountability, and continuous improvement.
• Implement lean manufacturing principles and support the development of manufacturing lines.
• Work with suppliers to resolve material issues and develop manufacturing documentation.
• Support rework and repair of returned products.

What you NEED to SUCCEED in this challenging role:

• Bachelor’s degree in relevant field required.
• 3+ years of experience in manufacturing engineering support in the medical device industry, with a focus on instrument manufacturing preferred.
• Familiarity with FDA regulations and cGMP guidelines desired.
• Strong problem-solving skills and ability to drive process improvements.
• Collaborative mindset with the capability to influence others in a fast-paced environment.
• Ability to work independently with moderate supervision, with keen attention to detail.
• Proficient in Microsoft Office Suite.
• Must be able to navigate facility and lift up to 25 pounds.