Manufacturing Manager
: Job Details :


Manufacturing Manager

Oxenham Group

Location: Sioux Falls,SD, USA

Date: 2024-12-24T02:05:16Z

Job Description:

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.

Apply Now!

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