Required Skills & Experience
- Bachelor’s or Master’s degree in Biomedical, Mechanical, Materials, or a related engineering discipline
- 7–10+ years of medical-device development experience
- Significant catheter-based device development experience
- Proven experience taking a Class II or Class III medical device from early development through design transfer and commercial manufacturing
- Hands-on catheter prototyping experience, including bonding, tipping, reflow, assembly, and troubleshooting
- Proficiency with SolidWorks or comparable CAD software
- Experience producing DHF documentation and supporting FDA submissions
- Strong knowledge of design controls, ISO 14971 risk management, ISO 13485, and FDA 21 CFR 820
- Experience managing suppliers and contract manufacturers
- Experience supporting production-line development, process validation, and scale-up
- Project-management experience involving schedules, deliverables, risks, and cross-functional execution •Strong written and verbal communication skills
Nice to Have Skills & Experience
- Energy-based or thermal ablation catheter experience, including RF, microwave, or cryo systems
- Experience authoring substantial portions of 510(k), De Novo, IDE, PMA, or CE Mark submissions
- Experience supporting GLP preclinical studies or early clinical trials
- Knowledge of ISO 10993 biocompatibility requirements
- EtO sterilization and ISO 11135 experience
- Packaging and shelf-life testing experience
- Usability engineering experience under IEC 62366
- Electrical-safety knowledge involving the IEC 60601 family
- Experience with DOE, gauge R&R, Cpk, and process characterization •PMP or equivalent formal project-management training
Job Description
Insight Global is seeking a Senior Biomedical Engineer for a top medical-device client developing innovative treatments for venous disease and lymphedema. This hands-on senior technical contributor will own catheter-based device development from early concept through verification, validation, design transfer, and manufacturing handoff. The engineer will combine CAD design, rapid prototyping, engineering testing, supplier management, regulatory documentation, and production-line development to deliver a thoroughly documented and commercially scalable medical device. This is an excellent opportunity for an experienced engineer who enjoys technical ownership, cross-functional leadership, and bringing complex Class II or Class III products to market.