Sr. Manager, Maintenance & Manufacturing Engineering

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  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.
  

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  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.
  

Job Scope

The Sr. Manager, Maintenance & Manufacturing Engineering will be responsible for leading the manufacturing engineering group and the maintenance engineering & maintenance technical group. This is a wide-reaching role where responsibilities will range from technical floor support, to leading development processes, process/product improvement projects, to contributing to investigations of technical issues with in-process or field returned products. Works closely with Quality and other Operations departments. Role with high visibility and interaction with senior level executives Supports all applicable regulations including but not limited to FDA, ISO, IVDD, and IVDR requirements.

Key Duties and Responsibilities

• Ownership of operation engineering plan to improve production processes, upgrades in equipment/layout changes to optimize production flow and efficiency, expanded capacity to support growth, and product quality improvements to achieve production of safe, effective, and compliant IVD and RUO instrumentation.
  
  Ownership of the development and execution of validation protocols (IQ/OQ/PQ/PV) for production equipment, laboratory equipment, utilities, and other related systems in an FDA regulated environment, as needed.
• Manage a multidisciplinary group of leaders and individual contributors from the maintenance engineering, process development engineering, metrology & manufacturing engineering teams. Teams may also include hourly personnel.
• Ensure all teams are aligned to company values and goals and collaborating on all stages for the product lifecycle.
• As the leader of the process development engineering group this role is responsible of working with NPI teams and vendors to work-in DFM concepts as well as managing the transfer of pilot processes from SDI and developing scale-up technologies.
• Post-launch design improvements are also within the scope of work. This role may support sites across Luminex and DiaSorin Molecular.
• As the leader of the manufacturing engineering group this role is responsible for industrializing, validating/revalidating manufacturing equipment and processes as well as daily process troubleshooting support (CAPA, NCs) and driving continuous improvement efforts.
• As the leader of the maintenance and metrology engineering group this role is responsible for the maintenance, troubleshooting & calibration of critical manufacturing as well as upgrades and needed design change proposals.
• Assist in transferring new products and processes into the Manufacturing department. Coordinate with Production Support & Service personnel and Supply Chain Personnel to ensure necessary supplies, equipment and facilities are in order to achieve the product transfers.
• Control the validation of new products and processes to meet or exceed specifications; develop operational procedures to ensure the new products being transferred into manufacturing can be transferred into the normal production department in a smooth orderly manner.
• Responsible for developing strategies to detect and prevent issues that affect safety, quality and throughput.
• Act at site for process engineer projects and activities that reduce safety risks, improve product quality/purity, enhance delivery capabilities and support cost improvements.
• Maintain operating performance of production related equipment according to manufacturer's preventative maintenance procedures and approved Company policy.
• Develop and revise specifications and procedures, protocols, studies and other documents as needed by the Company.
• Own CMMS system: administration, ensuring compliance of the records of critical equipment.
• Plans, implements, and executes engineering projects, including defining the project philosophy, activities, milestones, and staff requirements, per customer requirements.
• Lead continuous improvement programs to reduce cost and cycle times of products. Examine and implement lean manufacturing techniques.
• Partner with R&D as part of manufacturing transfer and scale up for new product introductions.
• Work with Production and Technical Support personnel to identify, isolate and correct technical challenges for improving product reproducibility.
• Engage with manufacturing teams to find opportunities and provide improved production capabilities.
• Manage department and project budgets and implementation schedules to plan and forecast.
• Develop staff and improve capabilities/talent of the organization to meet current and future business needs.
• Advise management of opportunities and risks and propose methods to improve product quality, customer service, department operations and costs.
• Responsible for providing technical direction and functional management of manufacturing engineers, maintenance engineers and maintenance technicians.
• Performs required administrative functions, including preparation of annual capital expenditure budget, equipment spares parts management budget, control of expenditures within approved limits, personnel administration and training, performance management, and managing communications with executive level staff.
• Responsible for carrying out capital projects, engineering design, development of specifications, defining scope of work, project planning and execution, as well as organizing and coordinating resources and budgets.
• Responsible for career management/development and providing high quality performance reviews, fostering a challenging and rewarding work culture where engineers and technicians can grow and contribute to their maximum potential,driving team engagement, morale, and overall team effectiveness
• Align manufacturing engineering, maintenance engineering, and maintenance technician support to match production schedules.
• Must be able to work flexible hours and respond to emergencies after work hours.
• Ensure engineering sustains effective engagement with the design transfer groups of new and changed product development, validation, and market release phases.
• For new product/process designs the manager is responsible for providing technical input to ensure product and systems are designed with safety, quality, scalability and sustainability as a top priority.
• Lead the industrialization of current and new processes. This includes lean process area design, development of process/production metrics and targets, visual management systems, etc.
• Mentor, coach, and train staff on validation practices, policies, and procedures required to support GMP operations
• Lead the engineering teams to successfully deliver validations (IQ/OQ/PQ/PV) for production equipment, laboratory equipment, utilities, product labeling, product packaging, and controlled manufacturing environments.
• Develop and manage project schedules to achieve aggressive program timelines by using parallel planning and leveraging cross-functional resources.
• Responsible for implementing robust change management systems to detect changes, control changes, and document changes made to the process and/or the equipment in order to protect 'validated state'.
• Perform capacity, equipment efficiency, and labor utilization analysis to optimize manufacturing processes. Identify opportunities for business process improvements and efficiencies.
• Manage technical resources consisting of engineers and technicians in the execution of projects and troubleshooting.
• Implement standard system for troubleshooting manufacturing processes/equipment and lead root cause investigations.
• Drive the investigation and response of NCMR's and related root-cause analysis to prevent recurrence that may result in poor quality or scrap.
• Lead and support the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation. Support/lead internal and external audit actions as needed.
• Work with other manufacturing support functions such as Production, Tech Ops, SD&I, Facilities/EHS, QA, RA.
• Recommend equipment purchases, repairs, upgrades, obsolescence, and maintenance schedule changes to improve equipment efficiency.
• Lead the design and development of tooling, fixtures, jigs, etc. needed to improve the performance of the equipment and/or improve product quality.
• Maintain schedules for all GMP systems/ lab equipment to ensure that they are requalified/revalidated/calibrated on time.
• Responsible for the installation, troubleshooting and maintenance of all manufacturing equipment.
• Responsible for the team that supports 'line down' calls. Ensure that production lines operate with minimum downtime and occurrences eliminated via robust solutions.
• Advise management of opportunities and risks and propose methods to improve product quality, customer service, department operations and costs.
• Responsible for the implementation and management of asset performance metrics (MTBF, MTRR,MTTF, OEE, etc) and visual management of KPIs.
• Responsible for the deployment of Total Productive Maintenance systems using tools such as Reliability Centered Maintenance methodology.
• Responsible for the accurate and timely documentation of all work performed in manufacturing equipment. Use data for trending and predictive maintenance systems.
• Responsible for performing assigned tasks in accordance with the company's quality policies and procedures per the applicable quality management system regulations as defined in the Quality Manual.
• Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies. Responsible for enforcing all EHS policies in their span of control.Violations of EHS regulations or policies will be handled in accordance with the established Company disciplinary process.
• Facilitate development and drive execution of operational goals aligned with company objectives.
• Lead and participate in cross-functional teams supporting local and global business process integration, improvement, and alignment initiatives.
• Participate in or conduct applicable departmental, interdepartmental and intradepartmental training.
• Participate in departmental and Operations strategic planning encompassing organization, equipment/facilities, capabilities, and priorities.
• Ensure departmental compliance and influence operational compliance with the Luminex Quality System including FDA, USDA, and ISO 13485 requirements.
• Ensure departmental adherence and influence operational adherence to safety, waste disposal, etc.
• Perform other duties as assigned.
• Establish and maintain standard architecture of BOMs and Routings to ensure accurate costing.
• Hire/retain competent talent for all groups. Establish and sustain a culture of collaboration, flexibility, accountability, transparency, and execution.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Interface with Cost Accounting for new or existing product COGs roll-up
• Deliver shipping configuration packaging and labeling design support in collaboration with Commercial Operations and Supply Chain. Assume full ownership at Production Release including shipping validations.

Education, Experience, and Qualifications

• Bachelor's Degree in a Mechanical, Electrical, or Industrial Engineering related discipline required
• Required 8+ Years Manufacturing Engineering, Process Engineering, Maintenance Engineering and/or Product Transfer focused operations experience in a relevant ISO 13485 and/or FDA regulated industry setting.
• 5+ years supervisory experience. The position requires three (3) years of product transfer experience or process development engineering experience.
• 2+ Years Operations leadership experience with direct management of teams required
• 2+ Years Experience with electromechanical assembly manufacturing required
• 1+ Years Experience with optical designs and calibration required
• Proficiency with 3D modeling and data analytics software (Solidworks and Minitab) is a plus.
• Knowledge of FDA QSR's and ISO regulations is highly preferred.
• Thorough knowledge of ISO 13485 and FDA Quality System requirements
• Proficiency in Enterprise Resource Planning and Manufacturing Execution systems desired
• Proficiency in the use of Product Lifecycle Management and Engineering Change Control tools
• Applied knowledge of equipment, process, test method, cleaning, and software validations as required by FDA Quality System guidelines.
• Thorough knowledge of Design Control requirements as defined by the FDA Quality System guidelines
• Proficiency in measurement and analysis systems
• Proficiency in data analysis tools, problem solving tools, and technical writing
• Proficiency in statistical process control desired
• Applied knowledge of Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments desired
• Working knowledge of cost accounting desired
• Strong mathematics and statistics aptitude
• Geometric Dimensioning & Tolerancing
• Understanding of adhesives/epoxies, surface treatments, glass working techniques, pouch fabrication, ultrasonic welding, PLC programming, Injection molding and material coatings, plastic molding, automated dispensing is a plus.
• Thrives in a fast-moving environment, is proactive and works well in a team
• Excellent oral and written communication skills
• Proficient in Microsoft Word, Excel, and PowerPoint programs.
• Highly organized with proven time management and prioritization skills
• Ability to handle the pressure of meeting tight deadlines and adapting to rapidly changing priorities

Physical Demands

• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel. The employee frequently is required to sit.
• The employee is occasionally required to stand, walk, reach with hands and arms, and talk or hear.
• The employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.

Work Environment

• While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals.
• The noise level in the work environment is usually moderate.

Travel Requirements

• 10% Domestic travel

What we offer

Salary Range

The hourly range for this position is $160,000 - $180,000 salary. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.