Head of Injection Molding
North Charleston, United States of America
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 is a foundational leadership role within our state-of-the-art drug delivery system manufacturing facility. The Head of Injection Molding will be instrumental in building and leading a high-performing molding operation, owning all aspects from the acceptance of new equipment to cultivating a culture of operational excellence. As a key member of the Site Leadership Team, this leader will guide the department through a period of significant expansion, owning the change management strategy required to triple production capacity while maintaining strict regulatory adherence and engaging with our global network.
Main Responsibilities
- Strategic & Financial:
- Develop and execute the annual operating plan for the Injection Molding department, including budgeting, resource planning, and setting performance objectives.
- Lead the strategic expansion of the molding department, overseeing the phased integration of new equipment to grow from 32 to 100 injection molding machines and from 1 to 4 vacuum forming machines.
- Serve as a key member of the Site Leadership Team, contributing to overall site strategy, policy, and cross-functional initiatives.
- Process & Tools:
- Champion a "LEAN mindset" throughout the department, driving continuous improvement initiatives to reduce waste and increase flow.
- Own the Overall Equipment Effectiveness (OEE) for all molding cells, implementing strategies to maximize availability, performance, and quality output.
- Mentor and guide the engineering team in structured problem-solving (e.g., RCA, DMAIC, 6M) to address complex technical and process-related challenges.
- Establish and oversee robust equipment maintenance strategies to ensure peak performance and product quality.
- People & Team Development:
- Partner with site leadership to build a world-class molding organization, executing a talent plan to recruit, train, and retain a team capable of supporting the site's 3x growth.
- Foster a culture of accountability where every team member feels ownership over quality and safety.
- Define clear roles and responsibilities, establishing a robust training and skills matrix to ensure operational readiness.
- Operational & Quality:
- Champion a 'Zero Defect' culture, driving a strategic initiative to reduce manufacturing-controllable non-conformances.
- Hold accountability to ensure all molding operations and documentation comply strictly with cGMP requirements, ISO 13485 standards, and internal SOPs.
- Act as the primary subject matter expert and departmental representative during customer and regulatory audits, building confidence through transparent and knowledgeable communication.
- Ensure deviation management, change control, and CAPA processes are executed diligently within the department.
Skills and Qualification
- Bachelor’s degree in Engineering (Mechanical, Plastics, or Industrial preferred) or equivalent education/experience.
- Minimum of 10 years of progressive experience in high-volume, precision injection molding.
- At least 5 years in a significant production management role, with direct leadership responsibility for a large team
- Demonstrated, hands-on experience in a highly regulated industry governed by ISO 13485 and/or FDA cGMP or equivalent
- Demonstrated success leading a manufacturing department through significant scaling or complex change management initiatives.
- Deep knowledge of molding process validation (IQ/OQ/PQ) and scientific molding principles.
- Six Sigma certification.
- Direct experience with Engel injection molding machines, Fanuc robotics, and centralized resin handling systems.
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