Research And Development Engineer- Medical Devices

Highbrow Technology Inc; Menlo Park (CA); On-site; USD 95,000 - 130,000; Full time

Job summary

Highbrow Technology Inc. seeks 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.

Qualifications

• BS Degree in Biomedical, Mechanical, Electrical, Biological, or Physical Science.
• 1+ year of relevant medical product development experience, or a graduate degree with project experience.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.

Responsibilities

• 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.

Skills

Biomedical

Mechanical

Electrical

Biological

Physical Science

Education

Bachelor's degree in Biomedical, Mechanical, Electrical, Biological, or Physical Science

Job description

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.