Sustaining Engineer — Med Devices & Global Compliance

Rhythmlink International, LLC; United States; On-site; USD 75,000 - 110,000; Full time

Job summary

Rhythmlink International, LLC in the United States is seeking a Sustaining Engineer to improve product performance, manufacturability, and regulatory compliance across a diverse medical device portfolio. You\'ll work with cross-functional teams to drive designs that enhance patient outcomes and meet global requirements.

The role emphasizes root-cause analysis, labeling projects, supplier qualification, and continuous improvement, with a focus on design controls and ISO requirements.

Qualifications

• Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering from an accredited college.
• 1-3 years of experience in medical device product development.
• Proficient in Microsoft Office and project management software.
• SolidWorks CAD experience.
• Knowledge of FDA design controls, ISO 13485, ISO 14971 and global regulatory requirements.
• Effective written and verbal communication.
• Ability to multitask and deliver on schedule.

Responsibilities

• Execute improvements to enhance 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, including labeling 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

Regulatory compliance

Root-cause analysis

Project management

Communication

Education

Bachelor’s Degree in Mechanical, Electrical or Biomedical Engineering

Tools

SolidWorks

MS Excel

MS Project

FDA design controls knowledge

Job description

Rhythmlink International, LLC in the United States is seeking a Sustaining Engineer to improve product performance, manufacturability, and regulatory compliance across a diverse medical device portfolio. You\'ll work with cross-functional teams to drive designs that enhance patient outcomes and meet global requirements.

The role emphasizes root-cause analysis, labeling projects, supplier qualification, and continuous improvement, with a focus on design controls and ISO requirements.