Research And Development Engineer

Lumin Innovations; Austin (TX); On-site; USD 55,000 - 62,000; Full time

Job summary

A leading company in medical device manufacturing is seeking a Research and Development Engineer to design and prototype innovative medical devices. The ideal candidate will have a strong background in biomedical or mechanical engineering, with at least 3 years of experience in the industry. Responsibilities include conducting feasibility studies, generating technical documentation, and collaborating with manufacturing teams to ensure design success. This role offers competitive compensation and the opportunity to work on cutting-edge medical technologies.

Qualifications

• Minimum of 3 years of hands-on R&D experience in the medical device industry.
• Proven expertise with CAD software (e.g., SolidWorks, AutoCAD).
• Familiarity with regulatory standards: FDA, ISO 13485, ISO 14971.

Responsibilities

• Design, prototype, and iterate medical device concepts using CAD.
• Conduct feasibility studies and risk assessments for new designs.
• Generate comprehensive technical documentation aligned with regulatory standards.

Skills

Analytical skills

Problem-solving capabilities

Communication skills

Project management abilities

Understanding of human anatomy

Education

Bachelor’s degree in Biomedical Engineering

Master’s or PhD preferred

Tools

CAD software

Simulation tools

Job description

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• Design, prototype, and iterate medical device concepts using CAD and rapid prototyping tools.
• Conduct feasibility studies, root cause analyses, and risk assessments (including FMEAs) to evaluate new designs.
• Define and develop design inputs and outputs, verification & validation plans, and test protocols.
• Generate comprehensive technical documentation aligned with FDA, ISO 13485, ISO 14971, and IEC 60601 standards.
• Participate in and support regulatory audits, design reviews, and milestone gate reviews.
• Collaborate with suppliers and manufacturing teams to ensure Design for Manufacturability (DFM) and Design for Reliability (DFR).
• Support clinical trial activities through engineering insights and troubleshooting.
• Monitor emerging medical technologies, materials, and engineering trends to inform product innovation.

Required Qualifications:

Education:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline.
• Advanced degree (Master’s or PhD) preferred.

Experience:

• Minimum of 3 years of hands-on R&D experience in the medical device industry.
• Proven expertise with CAD software (e.g., SolidWorks, AutoCAD).
• Familiarity with regulatory standards: FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 60601.
• Experience with design controls, risk management, and verification & validation processes.
• Understanding of biocompatible materials and sterilization techniques (EtO, Gamma, etc.) is an advantage.

Skills:

• Strong analytical and problem-solving capabilities.
• Excellent communication skills—both written and verbal.
• Effective multitasking and project management abilities.
• In-depth understanding of human anatomy, physiology, and medical device clinical applications.

Preferred Qualifications:

• Involvement in regulatory submissions such as 510(k) or CE Marking.
• Proficiency in simulation tools (e.g., ANSYS, COMSOL).
• Knowledge of embedded systems, sensors, or software-driven medical devices.
• Track record of patents or publications in medical technology.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Industries

  Medical Equipment Manufacturing

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