R&D Engineer III

Job Description

We are seeking a highly motivated R&D Engineer to support sustaining engineering activities for commercial medical devices throughout the product lifecycle. This role is responsible for maintaining product performance, regulatory compliance, manufacturing continuity, patient safety, and product quality by supporting design changes, technical investigations, and cross-functional engineering initiatives.

Note:

Applicants must be authorized to work in the U.S. without visa sponsorship now or in the future.

• Support commercial medical devices throughout the product lifecycle, including design changes, supplier and material changes, manufacturing support, quality investigations, shelf-life updates, labeling updates, and technical assessments.
• Compile, analyze, and report design, manufacturing, quality, complaint, testing, and research data.
• Utilize design change processes to evaluate and justify proposed product changes while ensuring design intent is maintained.
• Collaborate with project management, quality, manufacturing, regulatory, clinical, and marketing teams to ensure successful project execution.
• Partner with manufacturing teams to identify opportunities for product cost reduction through design improvements.
• Analyze market feedback and provide technical input to evaluate product performance and identify opportunities for design enhancements.
• Interface with vendors and healthcare professionals as required to support projects.
• Support quality investigations and provide technical expertise for design changes.
• Plan and manage assigned activities to meet project timelines.
• Troubleshoot product and process issues related to design, materials, and manufacturing processes.
• Analyze test results, prepare technical reports, and communicate findings to cross-functional teams.
• Provide technical guidance within multidisciplinary teams.
• Lead or participate in cross-functional problem-solving activities.
• Maintain a strong commitment to patient safety and product quality.

• Bachelor's degree with a minimum of 7 years of relevant experience, or
• Master's degree with a minimum of 5 years of relevant experience, or
• Ph.D. with a minimum of 3 years of relevant experience.
• Minimum of 5 years of experience in the medical device industry preferred.
• Experience with catheter-based disposable devices, intravascular devices, or Class II/III sterile single-use medical devices preferred.
• Experience with design controls, change control, risk management, design verification and validation, test method development, root cause analysis, and technical documentation in an FDA-regulated environment.
• Experience leading technical problem solving in cross-functional engineering environments.

• Sustaining engineering.
• Product lifecycle management.
• Design controls.
• Change control.
• Risk management.
• Design verification and validation (V&V).
• Test method development.
• Root cause analysis.
• Technical documentation.
• Manufacturing support.
• Quality investigations.
• Medical device regulations.
• Catheter design.
• Polymeric materials.
• Extrusion technologies.
• Bonding technologies.
• Adhesives and coatings.
• Laser welding.
• Sterilization processes.
• Packaging.
• High-volume disposable device manufacturing.
• Cross-functional collaboration.
• Technical problem-solving.
• Strong written and verbal communication skills.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science/Engineering, Polymer Engineering, Chemical Engineering, or a related technical discipline.
• Master's degree or Ph.D. in a related technical discipline is preferred based on experience requirements.

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement:
By applying, you acknowledge that AI-assisted tools may be used during hiring. #LI-BP1