Process Engineer - Assembly

Location: Charleston, South Carolina, US

Reporting to: Head of Device Assembly

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

We are seeking a skilled and detail-oriented Process Engineer to oversee and optimize our assembly operations. This role is critical in ensuring precision manufacturing, process efficiency, and quality control in the device assembly area. The ideal candidate will have a deep understanding of assembly processes and production optimization techniques.

Main Responsibilities

• Process Development & Optimization
• Design, develop, and maintain manual and automated assembly equipment
• Conduct time studies, root cause analyses, and implement process improvements to reduce cycle time, improve quality, and increase yield.
• Develop and maintain process documentation, including SOPs, work instructions, and setup sheets.
• Tooling and Equipment Support
• Specify, design, and troubleshoot tooling used in manual and automated assembly equipment
• Collaborate with tool and die makers for fabrication and repair of production tooling.
• Assist maintenance teams in diagnosing and resolving machine and tooling issues.
• Quality & Compliance
• Ensure processes meet quality standards and customer specifications through statistical process control (SPC) and capability studies.
• Work with the Quality Department to resolve non-conformances and implement corrective actions.
• Project Management & Cross-Functional Collaboration
• Lead or support projects involving new product introductions or capacity expansions.
• Collaborate with Design, Quality, Maintenance, and Production teams to ensure smooth process transitions.
• Training & Technical Support
• Provide technical support and training to operators and technicians on process best practices.
• Stay current with industry trends and new technologies to ensure competitive advantage.
  

Skills And Qualification

• Bachelor’s Degree (Engineering- Preferred) or equivalent experience
• Minimum 3-5 years of demonstrated success in a highly automated high-volume facility
• SME level knowledge of process automation technology
• Experience with CNC machines (sub 1 second cycle times)
• Above average knowledge of SAP and MES systems
• Excellent communication skills
  
  

Preferred

• Prior experience in highly regulated industry highly preferred
• Experience with operation and functionality of Cold Forming Metal machines
• Experience with operation and functionality of high-speed Spring forming machines
• Proficient understanding of Quality Management Systems (QMS) and their execution
• Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies. Six Sigma certification is a plus
• Ability to perform multiple tasks and prioritize workload.
• Effective analytical, technical, and problem-solving skills.
• Excellent intercultural and interdisciplinary communication skills
• Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost
• Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done
• Proficiency with all Microsoft products
  
  

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