Sustaining Engineer

Find Great People | FGP; Columbia (SC); On-site; USD 70,000 - 90,000; Full time

Job summary

Find Great People | FGP is seeking a Sustaining/Product Engineer in the medical device sector to manage lifecycle activities for released products and drive improvements in cost, reliability, and quality. The role requires close collaboration with regulatory, manufacturing, supply chain, and operations to ensure regulatory compliance and successful product updates.

The ideal candidate has a technical engineering degree and 1–3 years in medical device or regulated environments, with strong

Qualifications

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline.
• 1-3 years of experience in medical device engineering, product development, sustaining engineering, or a related field.
• Experience working within regulated product environments.
• Proficiency with Microsoft Office applications, including Excel and project management tools.
• Experience using CAD software such as SolidWorks.
• Strong analytical and problem‑solving skills, including root cause analysis and product troubleshooting.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects and priorities simultaneously.
• Strong attention to detail and commitment to meeting project deadlines.
• Proven ability to work effectively in a collaborative, cross‑functional team environment.

Responsibilities

• Support ongoing maintenance, enhancement, and lifecycle management of released medical device products.
• Drive product improvements focused on performance, manufacturability, reliability, cost reduction, and regulatory compliance.
• Conduct and support root cause investigations, corrective actions, and design updates.
• Manage product labeling updates to meet regulatory requirements and customer specifications.
• Support OEM and private-label product modifications while maintaining product integrity and customer satisfaction.
• Partner with regulatory teams to facilitate product registrations and market expansion activities in new countries and regions.
• Collaborate with manufacturing, supply chain, and operations teams to implement sustainable product and process improvements.
• Assist with second-source qualification projects to reduce supply risk and improve cost efficiency.
• Ensure compliance with design control requirements, quality system regulations, and applicable industry standards.
• Contribute to a culture of continuous improvement with a strong focus on quality and customer satisfaction.

Skills

Root cause analysis

Cross-functional collaboration

Project management

Analytical thinking

Communication skills

Attention to detail

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Microsoft Project

Job description

Sustaining/Product Engineer | Medical Device Industry

We are partnering with a growing medical device organization seeking a Sustaining/Product Engineer to support the lifecycle management and continuous improvement of commercially released products. This role is responsible for maintaining product performance, supporting regulatory compliance across global markets, driving cost and reliability improvements, and ensuring business continuity through product updates and sourcing initiatives. The successful candidate will collaborate cross-functionally with engineering, regulatory, manufacturing, supply chain, and operations teams to deliver impactful improvements to existing products.

Key Responsibilities

• Support ongoing maintenance, enhancement, and lifecycle management of released medical device products.
• Drive product improvements focused on performance, manufacturability, reliability, cost reduction, and regulatory compliance.
• Conduct and support root cause investigations, corrective actions, and design updates.
• Manage product labeling updates to meet regulatory requirements and customer specifications.
• Support OEM and private-label product modifications while maintaining product integrity and customer satisfaction.
• Partner with regulatory teams to facilitate product registrations and market expansion activities in new countries and regions.
• Collaborate with manufacturing, supply chain, and operations teams to implement sustainable product and process improvements.
• Assist with second-source qualification projects to reduce supply risk and improve cost efficiency.
• Ensure compliance with design control requirements, quality system regulations, and applicable industry standards.
• Contribute to a culture of continuous improvement with a strong focus on quality and customer satisfaction.

Qualifications

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline.
• 1-3 years of experience in medical device engineering, product development, sustaining engineering, or a related field.
• Experience working within regulated product environments.
• Proficiency with Microsoft Office applications, including Excel and project management tools.
• Experience using CAD software such as SolidWorks.
• Strong analytical and problem‑solving skills, including root cause analysis and product troubleshooting.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects and priorities simultaneously.
• Strong attention to detail and commitment to meeting project deadlines.
• Proven ability to work effectively in a collaborative, cross‑functional team environment.

Preferred Qualifications

• Knowledge of FDA design controls, ISO 13485, ISO 14971, and medical device risk management principles.
• Exposure to international regulatory requirements and global product registration activities.