Job Description

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.

Skills and Requirements

• 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
• 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

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.

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