Job Description
Our client seeks an experienced Senior R&D Manager/Director to lead the design, development, and verification of next-generation medical devices. Reporting to the CTO, the R&D Manager will have extensive experience in systems engineering, mechanical, and electronic hardware engineering.
* Manage a multi-disciplinary and multi-site R&D hardware team to develop next-generation products.
* Lead and direct system and hardware development activities for cutting-edge devices.
* Provide technical leadership through concept, prototype, design, and test development for medical devices.
* Manage resources, needs, costs, schedule, key milestones, scope, and development goals within the team according to company milestones.
* Lead DHF (Design History File) deliverables with key stakeholders and work within our design control process, meeting Quality Management System requirements.
* Ensure compliance with applicable standards and regulations, including FDA requirements and ISO standards.
* Communicate with external vendors to ensure design intent is translated into product effectively.
* Evaluate trade-off decisions and present actionable information to leadership stakeholders.
* Provide leadership with project planning and execution in parallel within the R&D department.
* Ensure effective communication and collaboration within the R&D team and foster a culture of innovation and continuous improvement.
* Contribute to the company's growing intellectual property portfolio through innovation and invention.
Required Skills and Qualifications
* 10+ years of experience in R&D leadership in the Medical Device Industry.
* Demonstrated track record in leading cross-functional, multi-site development activities to execute 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 across multiple sites.
* Experience in working within Quality systems for Medical device development.
* Experience in hardware and systems development of complex medical devices.
* Experience with design for manufacturing (DFM) and design for reliability (DFR) principles.
* Proven track record of leading successful product development programs.
* Master's degree in Mechanical/Electronic Engineering or related fields from an accredited college or university.
* Hands-on mindset and creativity for problem-solving within multi-disciplinary teams.
* Extensive experience in project management, preferably including agile methodologies.
Benefits
* Strong work ethics with a team-oriented mindset
* Ability to travel up to 25% annually within Europe and internationally