Senior Manufacturing Manager

Senior Manufacturing Manager, Instruments - 2

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and licensed technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin? Impactful Work : When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world. Global Reach & Innovation : Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry. Diverse and Inclusive Culture : We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

Join Our Team : If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward. Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

Job Scope : Senior Manufacturing Manager, Instruments - 2 leads the manufacturing operation of moderate to high span of control and complexity in the execution of a diverse instrument product portfolio serving the in-vitro diagnostic and research markets. This position is responsible for instrument manufacturing product realization leading to the production of safe, effective, and compliant IVD and / or RUO instrumentation. Accountable for financial performance of instrument manufacturing organization, adherence to all requirements of cGMP as applicable, management of direct reports and their staff, and execution of business plans.

Responsibilities and Duties :

Provide leadership and direct management of supervisory and direct employees in the instrument manufacturing.

Develop and execute plans and resource requirements to ensure fulfillment of production demand per business plan.

Ensure effective and compliant work instructions, training requirements, equipment management, and facilities.

Deliver design transfer requirements readiness and execution in partnership with manufacturing engineering for new product introduction and product changes.

Support planning and execution of equipment and process validations in partnership with manufacturing engineering.

Ensure accurate costing through effective management of make item BOM's, resource routing, lot size standards, and variances; anticipate forward looking cost change impacts relative to operational plans.

Plan and implement business process optimization and lean initiatives to eliminate waste and enhance control, responsiveness, and flexibility.

Identify and implement continuous improvement initiatives targeting quality, compliance, safety, efficiency, and cost.

Participate in planning and delivery of global business process integration, improvement, and harmonization initiatives.

Assist in design and implementation of infrastructure improvements affecting manufacturing.

Ensure effective development, monitoring, and reporting of performance metrics.

Collect, analyze and trend data and present data / findings / recommendations.

Effectively hire, train, develop, and evaluate staff in alignment with business needs. Take corrective action as necessary on a timely basis and in accordance with company policy. Ensure compliance with current federal, state, and local regulations in consultation with human resources as appropriate.

Ensure accuracy of operation specific job descriptions; ensure personnel awareness of job responsibilities and job performance connection to customer.

Ensure applicable standard operating procedure and task-specific training is timely and effective for department personnel.

Drive annual departmental capital, headcount, and expense budgeting requirements.

Authorize section expenditures and maintain accountability to budget integrity and financial performance.

Participate in development and drive execution to manufacturing MBO's.

Effectively engage with cross-functional operations to support the business.

Ensure effective prioritization, investigation, and resolution of findings impacting instrument manufacturing identified through audits, non-conformances, corrective / preventative actions, or customer complaint escalation.

Ensure operational compliance with the Luminex quality system including FDA and ISO 13485 requirements as applicable.

Ensure operational adherence to safety and waste disposal requirements.

Other duties as assigned.

Education, Experience and Qualifications :

Bachelor's degree in mechanical or electrical engineering related discipline or relevant scientific degree required.

10+ years relevant experience in a electromechanical assembly manufacturing environment required.

8+ years relevant manufacturing operations leadership experience required.

5+ years relevant experience in relevant ISO 13485 and / or FDA regulated setting preferred.

Training and Skills :

Thorough knowledge of ISO 13485 and FDA quality system requirements as applicable.

Thorough knowledge of design control requirements as defined by the FDA quality system guidelines as applicable.

Applied knowledge of equipment, process, test method, and software validations as required by FDA quality system guidelines as applicable.

Proven proficiency in promoting safety culture.

Proficiency in manufacturing resource planning and manufacturing execution systems such as Oracle or SAP preferred.

Proficiency in product lifecycle management tools preferred.

Proven results through application of lean manufacturing principles and applied knowledge of statistical design of experiments preferred.

Proficiency in statistical process control preferred.

Proficiency in data analysis tools, problem solving tools, and technical writing.

Applied knowledge of optical designs and calibration.

Proficiency in geometric dimensioning and tolerancing.

Standard Working Conditions :

Standing - frequently.

Stooping - occasionally.

Bending - occasionally.

Climbing - rarely.

Sitting - frequently.

Kneeling - rarely.

Lifting of at least 40lbs - occasionally.

Travel Requirements :

Up to 10% travel is estimated.

Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation, and dedication, we're the right company for you.