Senior Advanced Manufacturing Engineer

SHL Medical AG; North Charleston (SC); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive compensation

Modern facilities and technologies

Global team collaboration

Development opportunities

Job summary

SHL Medical in North Charleston, SC, is seeking an experienced Operations Engineer to bridge engineering and project management for end-to-end platform rollouts in our new manufacturing site.

You will collaborate with local and global stakeholders, owning technical responsibilities for product platforms from development to mass production while ensuring quality, regulatory compliance, and on-time delivery.

Qualifications

• Minimum 8 years of experience in industry with complex devices/manufacturing processes.
• Knowledge of ISO13485, 21 CFR 820 and GMP.

Responsibilities

• Provide overall technical responsibility for products/platforms in commercial manufacturing.
• Serve as SME for product, process, capacity and compliance knowledge.
• Drive process improvements across manufacturing steps from component production to final assembly and packaging.
• Collaborate with technicians, quality reps, maintenance and engineering to improve reliability and meet regulatory requirements.
• Serve as primary technical contact for complex production issues; lead RCA for complaints and quality events.
• Support capacity expansion and deployment at the site; liaise with global counterparts for knowledge sharing.
• Ensure change management and technology transfer for new products into mass production.
• Discuss technical aspects with external customers.

Skills

RCA methodologies

Intercultural communication

Education

Bachelor's degree in Mechanical 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 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

We like to keep things simple and efficient.
Once you’ve applied, it may take up to three weeks to review your application and get the first call with a recruiter.
Our recruitment process is focused on allowing you to show your personality, experience and competencies while giving you a great sense of who we are.

Grounded in belonging, we strive for excellence

With almost 6,000 employees of 77+ different nationalities, we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth. Together, we invest in our future to maintain our leadership position in drug delivery systems.