Job Title: Manufacturing Manager – Cartridge Production

Location: Sioux Falls, SD

Company Overview:

Our customer is a pioneering medical device company specializing in diagnostic platform technologies. The organization recently submitted a 510(k) application for its cutting-edge diagnostic platform. They are now expanding the team and seeking a Manufacturing Manager to lead cartridge production and kit development, including reagents and cartridges, at its Sioux Falls facility.

Position Overview:

The Manufacturing Manager will play a critical role in ensuring the successful production of diagnostic cartridges and reagents, driving operational excellence, and supporting assay development initiatives. This role requires a dynamic leader with Six Sigma background, strong project management skills, and hands-on experience in manufacturing operations. Expertise in antibodies and antigens is essential.

Key Responsibilities:

Manufacturing Leadership:

• Oversee the end-to-end manufacturing process for cartridge production, ensuring high-quality output and compliance with industry standards.
• Develop and implement scalable production workflows for cartridges and reagents.

Project Management:

• Lead cross-functional teams to execute manufacturing projects on time and within budget.
• Monitor project milestones and resolve bottlenecks efficiently.

Assay Development Support:

• Collaborate with R&D teams to integrate assay development needs into the manufacturing process.
• Ensure seamless transition from prototype to production stages.

Operational Excellence:

• Apply Six Sigma methodologies to enhance manufacturing processes and reduce variability.
• Identify and implement continuous improvement initiatives to drive efficiency and cost savings.

Team Management:

• Recruit, train, and mentor a skilled manufacturing team.
• Foster a culture of accountability, innovation, and collaboration.

Quality Assurance:

• Work with the quality team to ensure all manufacturing activities meet regulatory and quality standards.
• Maintain compliance with applicable FDA and ISO regulations.

Qualifications:

• Bachelor’s or Master’s degree in Engineering, Biochemistry, Biotechnology, or a related field.
• Minimum of 5 years’ experience in manufacturing management, preferably in the medical device or diagnostics industry.
• Proven expertise in Six Sigma principles with a Green or Black Belt certification.
• Demonstrated experience in assay development and production operations.
• Strong knowledge of antibodies and antigens.
• Exceptional project management skills with a track record of delivering complex initiatives.
• Excellent problem-solving, analytical, and decision-making abilities.
• Strong leadership and team development skills.

Preferred Skills:

• Familiarity with 510(k) regulatory requirements and submissions.
• Experience in developing manufacturing processes for diagnostic kits.
• Proficiency in ERP/MRP systems and lean manufacturing tools.