Sustaining Engineer - Medical Devices (Hybrid)

Rhythmlink International; Columbia (SC); Hybrid; USD 73,000 - 88,000; Full time

Job summary

Rhythmlink International in Columbia, SC is seeking a Sustaining Engineer to improve product performance, ensure regulatory compliance, and support customer satisfaction across a range of neurodiagnostic products.

You will apply your engineering background to drive design improvements, collaborate with regulatory and manufacturing, and manage labeling and updates to existing OEM products to maintain product integrity and market readiness.

Qualifications

• Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering from an accredited college or University.
• 1-3 years of experience in medical device product development or related experience.
• Experience with Microsoft Office (Excel, Project) and other project management software.
• Knowledge of CAD programs, such as Solidworks.
• Knowledge of FDA design controls, ISO 13485, ISO 14971 (risk management), and global regulatory requirements.
• Effective communication skills, both written and verbal.
• Ability to multitask.
• Attention to detail and timeliness of project delivery.

Responsibilities

• Execute improvements to product performance, manufacturability, and regulatory compliance.
• Utilize root-cause analyses, design updates, and reliability improvements.
• Execute labeling projects in compliance with regulatory and customer requirements.
• Execute updates to existing OEM products, ensuring product integrity and customer satisfaction.
• Collaborate with regulatory to bring products into new countries and markets, understanding all design areas to anticipate cause-and-effect, including labelling compliance.
• Interface with manufacturing, supply chain, and operations to implement sustainable improvements.
• Assist in second sourcing projects to qualify alternate suppliers and materials for risk mitigation and cost efficiency.
• Drive customer- and quality-focus, with a proactive mindset toward continuous improvement.
• Comply with requirements of design controls and other regulatory body requirements.

Skills

Medical device dev

Regulatory knowledge

Communication

Multitasking

Attention to detail

PM software

MS Office

Education

Bachelor’s Degree in Mechanical, Electrical or Biomedical Engineering

Tools

Solidworks

MS Excel

MS Project

Job description

Rhythmlink International in Columbia, SC is seeking a Sustaining Engineer to improve product performance, ensure regulatory compliance, and support customer satisfaction across a range of neurodiagnostic products.

You will apply your engineering background to drive design improvements, collaborate with regulatory and manufacturing, and manage labeling and updates to existing OEM products to maintain product integrity and market readiness.