Senior Process Engineer - Plastics

Process Engineer – Plastics

Location: Charleston, South Carolina, US

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 Manufacturing Engineering group within our Global Operations Engineering team at our new state-of-the-art device manufacturing facility in North Charleston, South Carolina.  This role is intended to serve as SHL’s in-house plastic engineering SME, specifically focused on owning our thermoforming processes for our internal packaging components, as well as supporting our internal injection molding engineers and their associated processes.

Main Responsibilities

• Serve as SHL’s thermoforming process SME, leading and supporting process introduction, development, troubleshooting, and improvement initiatives at the site
• Work with local operations and maintenance teams, as well as with global colleagues in the Process Development and Operations Engineers teams to drive new equipment & tooling introductions, as well as process improvements
• Interface and coordinate with tool shops and OEMs for new equipment requests, issue resolution, and documentation requests
• Support the internal injection molding engineering group as necessary, owning projects where applicable
• Work with fellow engineers in process development, product design, and quality engineering to drive and support root cause analysis, NCMR investigation/bounding, and CAPA planning & implementation
• Collaborate internally and across departments to review pFMEAs, ensure appropriate levels of risk mitigation, process monitoring, and detection for drift to help deliver and robust and repeatable manufacturing process
• Work closely with the Operations team to understand common issues, improve documentation, and increase overall process efficiency at the site
• Serve as the local site lead for capacity expansion with respect to thermoforming processes; support injection molding capacity expansion as needed
• Performs other related duties as assigned.

Skills and Qualification

• Bachelor’s degree in Engineering, Material/Polymer science, or equivalent education/experience required
• A minimum of 4 years of relevant experience as a plastics process engineer with a focus on thermoforming
• Understanding of the application of quality systems to the medical device industry
• Experience defining critical process parameters and setting allowable process windows for such variables
• Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies
• Experience troubleshooting and optimizing existing processes to improve OEE

Preferred: (nice to have)

• Ability to perform multiple tasks and prioritize workload.
• Effective analytical, technical, and problem-solving skills.
• Excellent intercultural and interdisciplinary communication skills
• Ability to work independently 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

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