Job Title: Senior R&D Manager/Director
Job Description
Our client is seeking an experienced Senior R&D Manager/Director to lead the development of next-generation medical devices. The ideal candidate will have a strong background in systems engineering, mechanical and electronic hardware engineering, and experience in managing cross-functional teams.
The successful candidate will be responsible for overseeing the design, development, and verification of medical devices, ensuring compliance with FDA and ISO standards and regulations. They will also provide technical leadership, manage resources, costs, schedules, key milestones, scope, and development goals within their team.
In addition, they will lead DHF (Design History File) deliverables with key stakeholders, work within our design control process, and meet Quality Management System requirements. Effective communication and collaboration with external vendors, as well as presenting actionable information to leadership stakeholders, are essential.
Required Skills and Qualifications
* 10+ years of experience in R&D leadership in the Medical Device Industry.
* Demonstrated track record in leading and managing cross-functional multi-site development activities to execute product development from early concept through commercialization.
* Strong technical expertise in systems engineering and expertise in complex electronic, mechatronic, and mechanical components.
* In-depth knowledge of applicable standards and regulations related to medical devices, including FDA requirements, notified bodies, and ISO standards.
* Strong interpersonal and leadership skills, managing cross-functional and multi-disciplinary teams across multiple sites.
Benefits
This is an excellent opportunity for an experienced R&D professional to take on a leadership role and drive the development of cutting-edge medical devices. If you have a passion for innovation and a proven track record in R&D leadership, we encourage you to apply.
Others
The successful candidate will be part of a dynamic team and will have the opportunity to contribute to the company's growing intellectual property portfolio through innovation and invention. A great attitude as a team player who excels in a demanding start-up environment is essential.