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.