Quality Manufacturing Engineer

Job Responsibility:

By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Position Summary:

We are seeking a highly skilled and experienced Quality Manufacturing Engineer to join our team. In this role, you will be responsible for ensuring the highest level of quality in the manufacturing process of complex consumables cartridges used for protein analysis. You will collaborate with cross-functional teams to develop and implement quality control measures, lead data-driven continuous improvement initiatives, and ensure compliance with industry standards and regulations. The ideal candidate will have a strong background in quality engineering, manufacturing processes, NPI, mechanical, electrical, optics and microfluidic principles.

Key Responsibilities:

• Develop and implement quality control and manufacturing processes and procedures for the manufacturing of complex consumable cartridges used for protein analysis.
• Collaborate with cross-functional teams, including design engineering, production, and supply chain, to ensure quality requirements are met throughout the manufacturing process.
• Responsible for processing NPI projects through structured gated system and will engage internal and external resources to ensure projects are delivered on time, cost, and quality.
• Conduct thorough analysis of manufacturing processes to identify areas for improvement and implement corrective actions to enhance product quality and efficiency.
• Lead and participate in root cause analysis and failure investigations to identify and resolve quality issues.
• Develop and maintain quality documentation, including work instructions, standard operating procedures, ECO, BOM and quality control plans.
• Responsible for developing tooling fixture.
• Experiencing in operating complex electrical-mechanical instruments and test fixtures and make suggestions for improvements.
• Perform regular audits and inspections to ensure compliance with quality standards, regulations, and customer requirements.
• Drive continuous improvement initiatives to optimize manufacturing processes, reduce defects, and improve overall product quality.
• Collaborate with suppliers to ensure the quality of incoming materials and components used in the manufacturing process.
• Provide technical expertise and support to resolve quality-related issues during production.
• Train and mentor manufacturing personnel on quality control and manufacturing processes and procedures.
• Must be able to travel domestically/internationally, North America, 10%

Education and Experience:

• Bachelor's degree in engineering or a related field.
• Minimum 5 to 7 years of experience in quality/manufacturing engineering within a manufacturing environment, preferably in medical devices.
• Experienced with microfluidics a plus
• Proficiency in testing and troubleshooting of complex consumable cartridges.
• Experience troubleshooting complex issues related to consumable cartridges and find root cause.
• Strong knowledge of quality control methodologies, tools, and techniques, such as statistical process control, Six Sigma, and lean manufacturing.
• Experience with complex electro-mechanical test instruments and familiarity with relevant industry standards and regulations.
• Proven track record of implementing quality control and manufacturing processes and driving continuous improvement initiatives.
• Excellent analytical and problem-solving skills, with the ability to conduct root cause analysis and implement effective corrective actions.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Detail-oriented mindset with a focus on delivering high-quality products.
• Familiarity with ISO 9001 and other relevant quality management systems. Knowledge of manufacturing processes, including assembly, testing, and inspection.
• Linux & Python experience is a plus.

• Note: This is intended to provide a general overview of the responsibilities and requirements of the position. It is not exhaustive and may be subject to change or modification to meet the company's evolving needs.