Associate Director of Operations

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 make a significant contribution to the world!

As they continue to grow exponentially, they are looking for an Associate Director of Operations to play a pivotal leadership role. This individual will oversee the establishment of new manufacturing operations for instruments and cartridges. Responsibilities include ensuring the successful delivery of a new manufacturing facility, resource scaling, implementing necessary equipment and automation, and establishing manufacturing processes that ensure the production of high-quality products, operational efficiency, and scalable infrastructure.

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 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 strategic startup operations alignment with company goals, overseeing Manufacturing, Engineering, and Design Transfer. 
  • Manage facilities and automation implementation, ensuring efficient, quality-focused manufacturing. 
  • Support complaint investigations, validate equipment and processes, and implement a Manufacturing Execution System. 
  • Ensure regulatory compliance, optimize processes, manage budgets, and foster a culture of collaboration and continuous improvement within the operations team.

What you NEED to SUCCEED in this challenging role:

  • A Bachelor’s degree in engineering, operations management, or a related field, or an equivalent combination of education and experience is required.
  • A minimum of 8 years of progressive experience in operations management, preferably in the medical device or healthcare industry, with demonstrated expertise in CFR820 and ISO 13485-2016 organizations is highly desirable.
  • Robust knowledge and experience in manufacturing operations, supply chain management, and regulatory compliance, including validation, are essential.
  • Proven track record of driving operational excellence, implementing process improvements, and optimizing costs, with a preference for experience in establishing new factories or implementing changes to existing ones.
  • Thorough understanding of regulatory requirements, adherence to quality standards, and application of manufacturing best practices.
  • Excellent communication and interpersonal skills, demonstrating the ability to collaborate effectively with stakeholders at all levels.
  • Strong leadership and mentoring capabilities, with a dedicated focus on developing and motivating team members.