Senior Design Engineer

Position Summary: We are seeking an experienced Senior Design Engineer to lead the design and development of innovative orthopedic medical devices from concept through commercialization. This is a hands-on engineering role for an individual who combines strong mechanical design capabilities with a practical understanding of anatomy, surgical procedures, manufacturing, and medical device design controls. The Senior Design Engineer will work closely with surgeons, manufacturing partners, quality and regulatory personnel, and commercial teams to translate clinical needs into safe, effective, manufacturable products. The ideal candidate has experience developing orthopedic implants and/or surgical instruments and is comfortable taking significant ownership of projects in a fast-paced, entrepreneurial environment.

Key Responsibilities: Lead mechanical design and development of orthopedic implants, instruments, and related surgical devices from concept through commercial release. Translate surgeon feedback, clinical requirements, and unmet procedural needs into engineering requirements and product concepts. Develop product concepts using CAD, rapid prototyping, tolerance analysis, material selection, and design-for-manufacturing principles. Create and maintain detailed 3D models, engineering drawings, specifications, bills of materials, and other design documentation. Plan, coordinate, and execute prototype development, bench testing, mechanical testing, and design verification activities. Develop test methods, fixtures, protocols, and reports to evaluate device performance against defined requirements. Participate in cadaveric evaluations, surgeon labs, and other product development activities involving clinical users. Support the complete design control process, including user needs, design inputs, design outputs, design reviews, verification, validation, and design transfer. Partner with Quality and Regulatory teams to support FDA submissions and other regulatory requirements. Work closely with contract manufacturers and suppliers to develop manufacturing processes, resolve technical issues, improve manufacturability, and establish production specifications. Support supplier selection, qualification, first-article evaluation, process validation, and manufacturing transfer. Investigate product and manufacturing issues and implement appropriate design or process improvements. Support existing commercial products through engineering changes, complaint investigations, CAPA activities, cost reduction, and continuous improvement. Maintain accurate and compliant engineering documentation within the company's Quality Management System. Manage multiple development projects and priorities while maintaining appropriate technical rigor and documentation.

Qualifications: RequiredBachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.5+ years of medical device product development experience, preferably involving orthopedic implants or surgical instrumentation. Demonstrated experience taking a medical device from concept through design verification, validation, and commercialization. Strong proficiency with 3D CAD and engineering drawing development. Strong understanding of mechanical design, materials, tolerancing, manufacturing processes, and design for manufacturability. Experience with medical device design controls and product development under an FDA-regulated Quality Management System. Experience developing and executing engineering test methods, protocols, and reports. Strong technical problem-solving and root-cause analysis skills. Ability to communicate effectively with surgeons, engineers, manufacturing partners, quality/regulatory personnel, and commercial teams.

Key Competencies: The successful candidate will be: Hands-on: Comfortable moving between CAD, prototypes, testing, manufacturing, and the operating-room environment. Clinically curious: Interested in understanding the surgical procedure and clinical problem, not simply designing to a specification. Practical: Able to balance technical elegance with manufacturability, cost, regulatory requirements, and commercial realities. Accountable: Comfortable owning projects and driving them forward with limited supervision. Collaborative: Able to work effectively with surgeons, suppliers, regulatory professionals, sales personnel, and other engineers. Detail-oriented: Understands that small design decisions can have significant consequences in an implantable medical device. Resourceful: Comfortable solving problems quickly and intelligently in an entrepreneurial environment where resources may be more limited than at a large orthopedic company.