Sustaining Engineer

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

Are you passionate about improving product performance, ensuring global compliance, and ensuring continued customer satisfaction? Then, joining Rhythmlink International as our next Sustaining Engineer is the right move for you. For 24 years we have set the bar as a dynamic and innovative team at the forefront of neurodiagnostic and neuromonitoring solutions. Our growth has been explosive, and our success has been unparalleled. We are ready to add a new Sustaining Engineer to our engineering team who is driven, motivated by challenge, and wants to make a real difference. You will do REAL work that WILL contribute to improving patient outcomes and healthcare practices worldwide.

Our employees are our number one asset and that’s not just lip service. We have been named to South Carolina’s Best Places to Work for 14 consecutive years! In addition to an outstanding health benefits package, we offer workplace health and fitness, regular company-provided lunch for employees, a generous PTO program, company-match retirement savings, and a culture that promotes teamwork, dedication, achievement and growth.

You will work with a team of people who are leading the way in enhancing manufacturability, reliability, and customer satisfaction across a diverse portfolio of products – while collaborating cross-functionally to bring impactful solutions to life.

As a Sustaining Engineer for Rhythmlink, you will leverage your engineering degree and experience to:

• 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, 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.

Do you have some/all of:

• 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 (including but not limited to MS Excel and MS Project) and other project management software.
• Knowledge of Computer-Aided Design 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 successfully multitask.
• Attention to detail and timeliness of project delivery.