Senior Production Engineer

SHL Group; North Charleston (SC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Modern facilities

Career development opportunities

International team collaboration

Job summary

SHL Medical in North Charleston, SC, is seeking an experienced Maintenance/Process Improvement professional to join our state-of-the-art device manufacturing facility embedded in the Component Production/Injection Molding area.

You will enhance reliability of core processes, lead improvement projects, support RCA, CAPA, and change control, and collaborate with cross-functional teams to optimize MTTR/MTBF and maintenance strategies in a regulated environment.

Qualifications

• Minimum 6 years of experience in Maintenance, Production, or Process Improvement, or related field.
• Expertise in 2 or more of injection molding, mold design and maintenance, production management, process improvement, RCA.
• Strong problem-solving skills, attention to detail, and ability to work independently.
• Experience in production planning, logistics, and process validation, with cross-functional teams.
• In regulated industries (medical/pharma) with knowledge of ISO 13485 and cGMP.

Responsibilities

• Enhance system and equipment reliability for core processes, focusing on people, process, equipment, and standards.
• Provide technical support for daily injection molding operations and develop Tool and Process Maintenance Technicians.
• Lead and support system and equipment reliability improvement projects.
• Drive performance improvements in molding processes and production assets using established process improvement systems.
• Lead and manage projects related to molding processes and assets.
• Participate in event response activities and support RCA to resolve equipment issues.
• Maintain and improve maintenance procedures and standards.
• Support technical documentation, including RCA, continuous improvement, CAPA, and change control.
• Improve MTTR and MTBF by optimizing maintenance standards, plans, and culture.
• Act as liaison with OEMs for parts complaints and ASL agreements, reducing maintenance costs.
• Strengthen relationships with production teams and maintenance planning.

Skills

Maintenance experience

Process improvement

RCA

Production management

Education

Bachelor’s degree in engineering

Job description

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 Component Production/Injection Molding of our new state-of-the-art device manufacturing facility in North Charleston, South Carolina.

Main Responsibilities

• Enhance system and equipment reliability for core processes, focusing on people, process, equipment, and standards.
• Provide technical support for daily injection molding operations and develop Tool and Process Maintenance Technicians.
• Lead and support system and equipment reliability improvement projects.
• Drive performance improvements in molding processes and production assets using established process improvement systems.
• Lead and manage projects related to molding processes and assets.
• Participate in event response activities and support Root Cause Analysis (RCA) to resolve equipment issues.
• Maintain and improve maintenance procedures and standards.
• Support technical documentation, including RCA, continuous improvement, CAPA, and change control. Improve Mean Time To Repair (MTTR) and Mean Time Between Failures (MTBF) by optimizing maintenance standards, plans, and culture.
• Act as liaison with OEMs for parts complaints and ASL agreements, reducing maintenance costs.
• Strengthen relationships with production teams and maintenance planning.

Skills and Qualification

• Minimum 6 years of experience in Maintenance, Production, or Process Improvement, or related field.
• Expertise in 2 or more of the following: injection molding, mold design and maintenance, production management, process improvement, RCA.
• Strong problem-solving skills, attention to detail, and ability to work independently.

• Experience in production planning, logistics, and process validation.
• Proven track record in maintenance planning and execution with cross-functional teams.
• Experience in a regulated industry (e.g., medical, pharmaceutical) with knowledge of standards like ISO 13485 and cGMP.

• Bachelor’s degree in engineering or a related field, or equivalent experience.

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