Research And Development Engineer- Medical Devices

We are seeking an R& D engineer with experience in medical product development, human factors/usability evaluation, anatomical model development, and verification & validation (V&V) testing
.

The ideal candidate will work closely with physicians, medical staff, and cross-functional teams including R&D, Marketing, Risk Management, Medical Affairs, Quality, and Regulatory Affairs
.

• Support usability testing, validation testing, model development, and technical protocol/report writing.
• Evaluate prototypes and simulate/test products to validate intended use requirements.
• Perform laboratory testing, data collection, analysis, and interpretation.
• Support human factors/usability analyses, feasibility studies, technology assessments, concept studies, benchmarking, and submission studies.
• Contribute to verification and validation activities for medical device products and subsystems.
• Analyze data from field studies and research activities.
• Prepare and maintain technical documentation, protocols, and reports.
• Ensure compliance with FDA regulations, Quality Management Systems (QMS), and other applicable regulatory requirements.
• Collaborate effectively with physicians, medical staff, engineers, and cross-functional stakeholders.
• Support additional projects and responsibilities as assigned.

• BS Degree in Biomedical, Mechanical, Electrical, Biological, or Physical Science
  .
• Minimum 1+ year of relevant experience in medical product development, or a graduate degree with relevant project experience.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Ability to work independently and as part of a cross-functional team.
• Strong organizational skills, attention to detail, and ability to meet deadlines.
• Ability to work effectively in a fast-paced and changing environment.
• Ability to travel approximately 10%, including internationally.
• Experience working within regulated environments is a plus.

• Master’s degree in Biomedical, Mechanical, Electrical, Biological, Physical Science, or Medicine.
• Advanced credentials in a relevant discipline, including Biomedical Sciences.
• Medical device industry experience.