Senior Manufacturing Manager, Instruments Job at Diasorin (Austin, Texas)

Job Description

Senior Manufacturing Manager, Instruments - 2 leads 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.

Job Responsibility

Provide leadership and direct management of supervisory and direct employees in the Instrument Manufacturing
Develop and execute plans and resource requirements (people, equipment, infrastructure) 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
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

Requirements

Bachelor's Degree Bachelor of Science 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
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

Nice to have

Proficiency in Manufacturing Resource Planning and Manufacturing Execution Systems such as Oracle or SAP
Proficiency in Product Lifecycle Management tools
Proven results through application of Lean Manufacturing principles and applied knowledge of statistical design of experiments
Proficiency in statistical process control
5+ Years Relevant experience in relevant ISO 13485 and/or FDA regulated setting

Diasorin - All Job Offers

Select Country

Senior Manufacturing Manager, Instruments

Job Description

Job Responsibility

Requirements

Nice to have

Looking for more opportunities?

Senior Manufacturing Manager, Instruments

Senior Manager Manufacturing Systems Engineering

Senior Manufacturing Systems Engineer: Automation

Senior Manager of Planning and Purchasing

Senior Manager, Engineering, Maintenance & Facilities

Senior Manufacturing Automated Test Design Engineer

Senior Manufacturing Systems Engineer: Automation

Senior Manufacturing Systems Engineer

Senior Manufacturing Test Engineer

Our AI answers in your language