We are looking for a Biomedical Engineer to help us bring our surgical navigation platform from a prototype in the office to a finished product in the operating room. This role is highly interdisciplinary — a unique opportunity to use your skills to make an impact on the R&D team, Quality team, and Clinical team. You will be expected to communicate your work in peer-reviewed journals and white papers.

Your first year at Illuminant will involve working in a team of committed clinicians and engineers to achieve regulatory clearance for our product. That’s right — you’ll be working on getting an FDA clearance under your belt in your first year. You will help design, test, and evaluate hardware from mechanical, electrical, and optical perspectives. You will setup, design, and carry out experiments and demos in real operating rooms on representative tissue. You will help refine specifications, contribute to our risk management process, and define processes related to manufacturing, assembly, and quality assurance.

Our ideal candidate will have deep experience in medical device development, preferably with products that span both hardware and software. They will have significant experience with the principles of hardware development, from design to test, and be confident in CAD. They have deep understanding of the FDA’s regulatory requirements for medical devices and will be comfortable reading and applying standards and guidances to reach compliance. They are strong technical communicators and are able to write high quality scientific papers, engineering studies, and grant applications. Most importantly, they are energized by the accelerated growth, deep autonomy, and trajectory-setting impact that comes with joining as an early engineer in a cross-functional role.

🛠️ What You Will Do

• Support the R&D team in design, build, and test for hardware assemblies, from CAD to realized product, using DFM and DFA principles.
• Support the Clinical team in architecting and carrying out bench top and clinical experiments, from protocol to bedside.
• Support the Quality team in document control, design control, and risk management by helping organize information, enhancing standard operating procedures, contributing to design requirements, and conducting failure modes and effects analyses.
• Define and help perform quality control on parts and assemblies, from receiving inspections to final approvals.
• Collaborate with and support other teammates in component selection, system integration, and system debug efforts.
• Identify, communicate, and evaluate vendors.
• Propose and lead future product development efforts.
• Lead technical design reviews.
• Communicate technical ideas in written and oral media, such as peer-reviewed research papers, applications for federal grants, and internal engineering studies.
  
  

🏅 Your Qualifications

• Committed to learning and using new skills to get the job done.
• Excellent foundation in experimental design and problem solving
• Excellent foundation in mechanical engineering and generally working with hardware
• Highly proficient in CAD and other hardware development tools
• Deep experience with medical devices and FDA regulation and guidances.
• Experience with Quality Systems
• Experience with user testing and usability
• Strong project management skills
• Comfortable with reading relevant research papers and synthesizing new insights.
• Comfortable with reading and applying regulatory standards and guidances to the design process.
• Comfortable in using hand tools, power tools, 3D printing, and other prototyping tools.
• Familiarity with cGMP a plus.
• Familiarity with software in medical devices a plus.
• Familiarity with design transfer to production a plus.
• Familiarity with mechanical drawings and GD&T a plus.
• Academic publications a plus.
• Preferred MS in Bioengineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related discipline.
• Preferred 3+ years of industry experience.