Engineering Manager - Medical Devices

Salary: $120,000 - 160,000/year with quarterly bonuses

We are seeking a highly skilled and motivated Engineering Manager to lead the development, design, and manufacturing of hardware and mechanical components for cutting-edge medical devices. This individual will manage a team of engineers responsible for bringing innovative products to market, ensuring compliance with medical device regulations, and driving continuous improvement in product quality and performance. The ideal candidate will possess a strong background in mechanical engineering, a deep understanding of medical device requirements, and proven leadership abilities.

• Lead, mentor, and develop a high-performing team of hardware and mechanical engineers, fostering a collaborative, innovative, and results-oriented work environment.
• Oversee the design, prototyping, testing, and optimization of mechanical and hardware components for medical devices, ensuring they meet functional, performance, and regulatory requirements.
• Manage multiple projects simultaneously, ensuring they are delivered on time, within budget, and to the highest standards of quality. Lead project planning, resource allocation, and risk management.
• Work closely with other departments (software, regulatory, quality assurance, manufacturing) to ensure seamless integration of hardware components into medical devices and ensure compliance with industry standards (e.g., ISO 13485, FDA regulations).
• Ensure all hardware and mechanical designs comply with relevant medical device regulations (e.g., FDA, CE marking). Lead the preparation and review of technical documentation for regulatory submissions and audits.
• Collaborate with the manufacturing team to ensure product designs are optimized for cost-effective and scalable production. Implement improvements in the manufacturing process to enhance efficiency, reduce waste, and improve product quality.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Master’s degree or MBA is a plus.
• 5+ years of experience in hardware and mechanical engineering, with at least 3 years in a leadership role managing teams in the medical device industry.
• Proven track record of designing and delivering complex hardware and mechanical components for medical devices.
• Strong knowledge of medical device design control processes, risk management, and regulatory requirements (FDA, ISO 13485).