Senior Manufacturing Engineer - Medical Devices & Process

SHL Medical US MFG LLC; North Charleston (SC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive compensation package

State-of-the-art facility

Global team collaboration

Job summary

SHL Medical is seeking a Senior Advanced Manufacturing Engineer for its new state-of-the-art device manufacturing facility in North Charleston, SC. The role sits in the Operations Engineering group, bridging technical engineering and project management to support end-to-end processes for platform devices at scale.

You will work with local and global stakeholders to drive roll-out and delivery, interfacing with clients to provide status updates on customer-specific products and ensuring compliant

Qualifications

• Minimum of 8 years of relevant experience in industry working on complex devices and manufacturing processes.
• Knowledge of medical device quality management system (ISO13485, 21 CFR 820) and 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.

Responsibilities

• Overall technical responsibility for products/platforms introduced into commercial manufacturing at the site.
• SME for product, process, capacity and compliance knowledge related to a specific product/platform.
• Drive improvements for processes involved in manufacturing the platform products from internal and external sources to final assembly and packaging.
• Collaborate with production technicians, quality, maintenance, and engineering peers to improve process & equipment reliability to meet requirements.
• Primary contact for complex technical issues in production; RCA lead for complaints and quality events.
• Support cross-functional capacity expansion and production deployment at the local site.
• Liaise with global counterparts to ensure cross-site knowledge sharing and alignment.
• Ensure effective and compliant change management and transfer of new products into mass production.

Skills

Communication skills

Root Cause Analysis

Problem solving

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical Engineering or related field

Job description

SHL Medical is seeking a Senior Advanced Manufacturing Engineer for its new state-of-the-art device manufacturing facility in North Charleston, SC. The role sits in the Operations Engineering group, bridging technical engineering and project management to support end-to-end processes for platform devices at scale.

You will work with local and global stakeholders to drive roll-out and delivery, interfacing with clients to provide status updates on customer-specific products and ensuring compliant