SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

This is a leadership role in the Production department of our new state-of-the-art device manufacturing facility in North Charleston, South Carolina, as a part of SHL’s Global Manufacturing Operations Network. As this is a new facility, the Head of Device Assembly will take an integral role in setting up the entire assembly operation for the site.

Main Responsibilities

• Provide Health, Safety and Environmental (HSE) and Quality leadership for the Device Assembly team
• Support Site Leadership to build a diverse and capable site organization based in engineering first principles and operational excellence. Talent management, development, and retention within the SHL Charleston organization (and beyond)
• Provide assembly teams with clear objectives to deliver Business and Strategic Plan Goals as it relates to safety, quality, and equipment/process effectiveness and efficiency
• Plan, coordinate and manage cost effective production strategies for device assembly operations to meet production cost targets, schedules, and quality control standards
• Interview and select subordinate staff. Define training and development requirements and ensure the appropriate training of personnel
• Responsible for managing the entire device assembly operation of the facility on a day-to-day basis
• Responsible for ensuring all assembly production activities comply with SHL standard operating procedures, applicable cGMP requirements and associated quality standards
• Responsible for ensuring continuous monitoring and accurate reporting of all relevant performance KPI of the assembly operation
• Responsible for receiving and integrating new equipment into the device assembly operation and responsible for establishing and executing plans to ramp-up equipment to the required target output and performance
• Responsible for establishing and executing equipment maintenance strategies to ensure product quality and equipment performance is maintained
• Responsible for implementing continuous improvement plans in device assembly in close collaboration with site quality and engineering functions
• Securing a business-focused prioritization of resources and materials (facility, manpower, components, packing material, etc.)
• Partner with Supply Chain, Quality and Engineering leadership to deliver operational results and to ensure efficient and timely resolution of day-to-day production issues
• Understand and influence the manufacturing control strategy for device assembly, and packaging
• Ensure practice matches procedure in responsible area

Skills and Qualification

• Degree in Engineering or equivalent education/experience
• Minimum 10 years relevant industry experience in high-volume plastic and metal component assembly and production management / assembly automation and inspection technology
• Relevant experience in managing automated assembly operation, including work-force planning, material logistics, equipment maintenance, quality management and finished goods packaging.
• Experienced and proficient in understanding how Total Effective Equipment Performance can be maximized.
• Several years of hands-on manufacturing experience in a 24/7 high-volume production setting.
• Previous exposure to a highly regulated industry (e.g., medical, pharmaceutical) and knowledge of relevant standards (e.g., ISO13485, cGMP) is a major plus
• Experience in Six Sigma methodologies is preferred.
• Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done
• Ability to work independent with strong attention to detail and focus on efficiency, effectiveness, and cost.
• Willingness to work from/relocate to Charleston, South Carolina is required.
• Willingness to initially spend an extended period in our facility in Taiwan for induction/training is a plus
• Excellent intercultural and interdisciplinary communication skills; Good at building a professional network

Physical Demands

The physical demands described here are representative of those that must be met by and employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit, and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel objects; and reach with hands and arms. The employee must regularly lift and /or move up to 10 pounds.

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization