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About the Role

As the Diagnostics Specialist, you will assume principal ownership of defined Manufacturing sections and/or product lines, supervising associated manufacturing staff. You will be responsible for delivering manufacturing requirements according to production schedules, including support for new product integration, process development, and validations. This role involves leading and engaging production teams, planning, coordinating, and supervising daily activities to ensure efficient production in a high complexity, small/large run manufacturing environment for Luminex instrument product lines within an ISO certified and FDA regulated setting.

Responsibilities

Coordinate the daily work schedule, priorities, and task delegation within a work section.
Supervise associated manufacturing personnel.
Establish, execute, and maintain role-specific training plans.
Deliver manufacturing requirements and attainment of production schedule for responsible Manufacturing section and/or product lines.
Deliver timely completion of manufacturing sections of process documentation and related business system transactions.
Oversee section cycle counts and physical inventory.
Oversee specific calibration and maintenance of manufacturing equipment and infrastructure.
Document non-conformances and participate in Material Review Board.
Participate in the integration of new products and processes into the Manufacturing organization.
Identify process improvements to enhance quality and efficiency.
Participate in sustaining projects for improvement of manufacturing processes, cleaning processes, product specifications, process/test equipment/fixtures, analysis tools, and business systems.
Participate in equipment and process validations.
Participate in or lead investigations and resolution of findings impacting the Instrument Manufacturing Organization.
Develop and/or update work instructions for new and/or improved processes.
Maintain cleanliness and integrity of manufacturing and storage areas.
Lead and/or participate in departmental and interdepartmental training.
Interface with other departments as required.
Maintain personal and departmental compliance with the Quality Management System.
Adhere to safety, disposal, and/or gowning requirements.
Perform change control review as required.
Drive document change control and basic engineering change control activities specific to Manufacturing section and/or product lines.
Manage Manufacturing section and/or product line specific labor routings and lead times for optimal accuracy.
Facilitate definition of labor routings and lead times for new product introductions.

Requirements

Associate Degree in Engineering/Engineering Technology or related field with equivalent experience required.
Bachelor's Degree in Engineering/Engineering Technology or related field preferred.
5+ Years relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization with a Bachelor’s Degree preferred.
8+ Years relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization with an Associate Degree required.
2+ Years relevant Manufacturing Operations leadership experience required.
Individuals hired will be required to verify identity and eligibility to work.
May be subject to a background check and drug screening where permitted by law.

Skills

Mathematics aptitude (High proficiency)
Electro-Mechanical Assembly knowledge (High proficiency)
Statistical aptitude (Low proficiency)
Clean manufacturing environments knowledge (Low proficiency)
ISO 13485 and FDA Quality System knowledge (Medium proficiency)
Proficiency in process-based Manufacturing Resource Planning systems such as Oracle or SAP (Medium proficiency)

Location

Onsite

Work Type

Full-time
Second shift coverage may be required - Occasionally
Swing shift coverage may be required - Occasionally

Experience Level

2+ Years Manufacturing Operations leadership experience

Education Level

Associate's Degree
Bachelor's Degree

About the Company

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide.
For more than 50 years, Diasorin has combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.
Diasorin continuously invests in research, technology, and people.
Guided by values of operational excellence, customer focus, and teamwork, Diasorin empowers teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios.
Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers.
Diasorin believes diverse perspectives strengthen innovation and help deliver meaningful impact for patients and customers worldwide.

Equal Opportunity

Diasorin is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.
This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located.
Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process.