Job Title: Lead Innovation Strategist for Next-Generation Devices
We are seeking an accomplished Senior R&D Manager/Director to spearhead the development and verification of cutting-edge devices. As a key member of our team, you will oversee the design, development, and commercialization of innovative products.
Key Responsibilities:
* Lead a multi-disciplinary team in designing and developing next-generation products.
* Direct system and hardware development activities for high-tech devices.
* Provide technical leadership for developments through concept, prototype, design, and testing phases.
* Manage resources, costs, schedules, key milestones, scope, and development goals within your team.
* Ensure compliance with applicable standards and regulations, including FDA requirements and ISO standards.
* Collaborate with external vendors to ensure design intent is translated into product effectively.
* Evaluate trade-off decisions and present actionable information to stakeholders.
* Plan and execute multiple projects in parallel within the R&D department.
* Foster a culture of innovation and continuous improvement within the R&D team.
Requirements:
* 10+ years of experience in R&D leadership in the Medical Device Industry.
* Demonstrated track record in leading cross-functional teams in executing product development from early concept through commercialization.
* Strong technical expertise in systems engineering and complex electronic, mechatronic, and mechanical components.
* In-depth knowledge of applicable standards and regulations related to medical devices.
* Strong interpersonal and leadership skills, managing cross-functional teams.
* Experience in working within Quality systems for Medical device development.
* Experience in hardware and systems development of complex medical devices.
* Hands-on mindset and creativity for problem-solving within multi-disciplinary teams.
* Extensive experience in project management, preferably including agile methodologies.
* Excellent communication skills in English.
* Ability to travel up to 25% annually within Europe as well as internationally.