
11 - 50 employees
🏥 Healthcare
💼 Consulting
🏭 Manufacturing
Healthcare • Consulting • Manufacturing
Genesis Innovation Group is a U. S. -based medical device development firm that partners with inventors and entrepreneurs to take medical technologies from ideation through engineering, regulatory clearance, manufacturing, and commercialization. The company provides end-to-end services including prototype development, additive and precision manufacturing, ISO 13485 and 510(k)/PMA regulatory support, clinical and market strategy, funding and business planning, and distribution and training for clinicians. With experienced multidisciplinary teams and industry relationships, Genesis guides clients through complex technical, quality, and commercial pathways to bring devices to market.
🔥 0 minutes ago
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11 - 50 employees
🏥 Healthcare
💼 Consulting
🏭 Manufacturing
Healthcare • Consulting • Manufacturing
Genesis Innovation Group is a U. S. -based medical device development firm that partners with inventors and entrepreneurs to take medical technologies from ideation through engineering, regulatory clearance, manufacturing, and commercialization. The company provides end-to-end services including prototype development, additive and precision manufacturing, ISO 13485 and 510(k)/PMA regulatory support, clinical and market strategy, funding and business planning, and distribution and training for clinicians. With experienced multidisciplinary teams and industry relationships, Genesis guides clients through complex technical, quality, and commercial pathways to bring devices to market.
• Design, develop, and test medical and surgical components, equipment, and instruments • Lead projects from initial design conception through production • Manage project timelines, goals, budgets, task assignments, and expenditures • Interact with surgeon customers regarding product improvements and new instrument ideas • Coordinate cross-functional teams for technical and creative alignment • Monitor and review team members’ work for quality • Own regulatory clearance planning and strategy pathway • Maintain regulatory submission and quality management system documentation • Make design decisions and tradeoffs • Create and modify detailed CAD models and technical drawings • Deliver complex products to test laboratories • Conduct tests evaluating product performance, safety, and functionality • Troubleshoot testing issues and evaluate questionable test results • Build relationships with surgeons, clients, and suppliers • Incorporate stakeholder feedback into design and development • Participate in continuous improvement initiatives • Provide technical advice affecting other teams and the company
• Bachelor of Science in Engineering or related degree required; advanced degree preferred • Specific medical design experience required • Minimum of 7 years in medical (orthopedics) product development or a related field with demonstrated industry knowledge • Experience with Design Controls and Risk Management preferred • Ability to empathize with users such as surgeons, scrub techs, and sales representatives • Ability to work individually and on a team • Ability to produce well-written post-training reports and provide written metrics and feedback • High attention to detail • Travel up to 40% of the time
• Bonus program • Benefits • Competitive wages • Great company culture • Opportunities for professional growth • Strong team collaboration
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