Manufacturing Engineer (Cartridge)

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 their exponential growth persists, they seek a Manufacturing Engineer (Cartridge) to offer technical assistance to the company’s cGMP manufacturing operations. This position will primarily concentrate on high-volume consumables production, directly collaborating with Quality Assurance, Production personnel, Supply Chain, Engineering, and Assay Development teams. The goal is to guarantee the timely delivery of premium consumables in alignment with the company’s expansion and supply requirements.

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: 

• Oversee manufacturing engineering activities including validation, test equipment design, and automation implementation. 
• Collaborate with Development teams for engineering changes and ensure adherence to FDA regulations and GMP guidelines. 
• Resolve production issues, support compliance audits, and promote a culture of continuous improvement. 
• Develop manufacturing instructions, streamline operations using lean principles, and support manual and automated production lines. 
• Address material issues with suppliers, create manufacturing documentation, and prioritize safety protocols.

What you NEED to SUCCEED in this challenging role:

• Bachelor’s degree in a relevant field is required.
• 3+ years of experience in manufacturing engineering support in the medical device industry, preferably in instrument or high-volume consumable manufacturing.
• Familiarity with FDA regulations and cGMP guidelines like CFR820 and ISO13485-2016 is desired.
• Strong problem-solving skills and ability to drive process improvements.
• Collaborative mindset with the capability to influence others in a fast-paced environment.
• Can work independently with moderate supervision, with keen attention to detail and organizational skills.
• Proficient in Microsoft Office Suite or similar software.
• Must be able to traverse the facility and lift up to 25 pounds.