Sr. Manufacturing Engineering Technician
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 Sr. Manufacturing Engineering Technician to provide technical assistance to the company’s cGMP manufacturing operations. This includes supporting instrumentation and high-volume consumable manufacturing, as well as instrumentation depot repair. The role involves direct collaboration with Quality Assurance, Supply Chain, Engineering, and Assay Development teams to guarantee the punctual delivery of top-notch, compliant products that align 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:
- Support manufacturing engineering activities including validations, test equipment design, process development, and automation.
- Implement proactive corrective actions and process efficiency improvements. Ensure compliance with FDA regulations and GMP guidelines.
- Assist in CAPAs and Non-Conformance investigations. Support compliance audits and troubleshooting of automation equipment.
- Develop Manufacturing Instructions and training materials. Enhance compliance and accountability processes.
- Provide support for instrument troubleshooting, assembly, and testing.
- Upgrade test equipment and resolve materials issues with suppliers.
- Support rework and repair of returned products.
- Enforce safety protocols and investigate safety incidents.
What you NEED to SUCCEED in this challenging role:
- Associate degree or equivalent experience required, preferably with 3+ years in medical device engineering support.
- Familiarity with FDA regulations and cGMP guidelines is preferred.
- Strong problem-solving skills, ability to collaborate, work independently, and prioritize tasks.
- Proficient in Microsoft Office. Must navigate the facility and lift 25 pounds.