Senior Medical Device Manufacturing Engineer - Platform

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 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.