Senior Development Engineer

🔥 12 minutes ago

🚗 Michigan – Remote

🚗 Michigan – Remote

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

👻 Ghost score 12%

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Genesis Innovation Group

WebsiteLinkedInAll Job Openings

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.

📋 Description

• Manage projects from initial concept through production, ensuring timely completion and adherence to project goals • Interact with surgeon customers regarding product improvements and new instrument ideas • Coordinate with cross-functional teams for technical and creative alignment • Create project plans and assign tasks to team members • Monitor and review team members' work for quality • Manage project budgets and monitor expenditures • Own regulatory clearance planning and strategy pathway for team lead approval • Maintain documentation for regulatory submissions and quality management systems • Lead design and development of medical and surgical components, equipment, and instruments • Make well-reasoned design decisions and tradeoffs • Create and modify detailed CAD models and technical drawings • Deliver complex products to test labs • Conduct tests evaluating product performance, safety, and functionality • Troubleshoot testing issues and evaluate questionable results • Build relationships with surgeons, clients, and suppliers • Incorporate stakeholder feedback into design and development • Participate in continuous improvement initiatives • Provide technical advice and contribute to technical decisions affecting other teams or the company

🎯 Requirements

• 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

🏖️ Benefits

• Competitive wages • Bonus program • Benefits • Great company culture • Opportunities for professional growth • Strong team collaboration

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