Senior Manufacturing Manager, Instruments - 2

DiaSorin•Austin, TX

33d

About The Position

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.

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

Responsibilities

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. 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.