We are seeking a highly experienced Hardware Manager to join our dynamic team. This role involves developing new products in the medical device industry, requiring strong mechatronics engineering competencies and experience. The Senior Hardware Manager will play a critical role from conceptual design through market release, ensuring compliance with all relevant medical device standards. 

Management: 

• Lead the hardware development team in designing, developing, and industrializing medical devices. 

• Oversee the entire development lifecycle, ensuring timely delivery of high-quality products. 

• Collaborate with cross-functional teams to ensure cohesive product development. 

• Manage external partners, including suppliers and subcontractors. 

• Define and maintain team budget and report activities to management. 

• Ensure team growth through objectives, formal training, and mentoring. 

Compliance: 

• Ensure compliance of activities with IEC 60601, ISO 13485, FDA 21 CFR Part 820, CE marking, and existing QMS. 

• Develop and maintain technical documentation, including design specifications, design outputs and test protocols 

• Conduct design reviews, FMEA, and other risk assessment activities. 

• Ensure Design Transfer readiness of HW sub-systems, through DFM and DFR approaches. 

Hands-On Implementation: 

• Manage and contribute to design, assembly, testing of mechanical and electronical components 

• Conduct testing, verification, troubleshooting, and issue solving activities. 

• Conduct root cause analysis and implement preventive and corrective actions. 

Proof of Concept (PoC) integration: 

• Ensure integration of POCs (Proof of Concept) and Prototypes into a compliant System design.

Required Skills and Experience: 

• Bachelor’s or master’s degree in mechanics, mechatronics, robotics, or a related field. 

• 10+ years of experience in hardware development for complex medical devices, in design and post market phases. 

• At least 5 years as a hardware manager. 

• In-depth knowledge of medical device standards and regulations. 

• Strong understanding of electrical and electronic design principles. 

• Experience with DFM, DFR, and mechatronics. 

• Experience with hardware/firmware/automation integration. 

• Excellent problem-solving, project management, communication, and leadership skills. 

Preferred Skills and Experience: 

• Experience with orthopedic devices and ASTM F1264. 

• Experience with robotic systems (mechatronics and mechanical). 

• Knowledge of GMP. 

• Knowledge of integration of control algorithms for robotic movements.