SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

This role is embedded in the Operations Engineering group at our new state-of-the-art device manufacturing facility in North Charleston, South Carolina.  This function bridges technical engineering and project management by supporting and owning the end-to-end processes associated with our product platforms. You will work closely with other key stakeholders and senior management, both locally and globally, to drive roll-out and delivery of quality platform devices at scale.  This role also includes interfacing with clients to provide status updates on customer-specific products.

Main Responsibilities

• Overall technical responsibility and subject matter expect for products/platforms introduced into commercial manufacturing at the site
• SME for product, process, capacity and compliance knowledge related to a specific product/platform
• Understand and drive improvements for the various processes involved in manufacturing the platform products from internal component production and external material supplies to final assembly processes and packaging
• Collaborate with production technicians, quality representatives, maintenance, and engineering peers to improve process & equipment reliability for the associated processes to meet all customer, business & regulatory requirements
• Primary contact for any complex technical issues of the product in production. RCA lead in case of complaints, NCMRs or other quality events
• Support corss-functional capacity expansion and production deployment at the local site
• Liaise with global counterparts to ensure cross-site knowledge sharing and alignment on issues, improvements, and status updates
• Ensure effective and compliant change management and implementation for related product/platform activities
• Manage technology transfer (receiver function) of new products and platforms into mass production
• Support the technical discussion with external customer 
• Performs other related duties as assigned.

Skills and Qualification 

• Minimum of 8 years of relevant experience in industry working on complex devices and manufacturing processes
• Knowledge of medical device quality managmenet system (ISO13485, 21 CFR 820) and Good Manufacturing Practices (GMP)
• Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies
• Direct experience in the medical device industry and understanding of the relevant regulations and regulatory bodies
• Excellent intercultural and interdisciplinary communication skills
• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Product Design, Biomedical, or equivalent education in engineering & sciences

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

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit: shl-medical.com