Senior R&D Manager/Director
We are seeking a seasoned leader to manage the design, development and verification of next-generation devices.
This role involves extensive experience in systems engineering, mechanical, and electronic hardware engineering. The ideal candidate will have a strong background in developing medical devices in compliance with applicable FDA and ISO standards and regulations (CFR as well as MDD).
Key Responsibilities:
* Lead and direct system and hardware development activities for cutting-edge devices.
* Provide technical leadership for developments through concept, prototype, design, and test development for medical devices.
* Manage resources needs, costs, schedule, key milestones, scope, and development goals within your team according to company milestones.
* Ensure compliance with applicable standards and regulations, including FDA requirements, notified bodies, and ISO standards.
* Evaluate trade-off decisions and present actionable information to leadership stakeholders.
* Communicate with external vendors to ensure design intent is translated into product effectively.
Required Skills/Experience:
* 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, preferably with imaging systems.
* 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.
* Proven track record of leading successful product development programs, from concept through commercialization.
* Master's degree in Mechanical/Electronic Engineering or related fields from an accredited college or university is preferred.
Additional Qualifications:
* Experience in working within Quality systems for Medical device development.
* Hands-on mindset and creativity for problem-solving within multi-disciplinary teams.
* Extensive experience in project management, preferably including agile methodologies.
About This Opportunity:
This is a unique opportunity to join our organization and contribute to the development of innovative medical devices. If you are a motivated and experienced leader looking for a new challenge, we encourage you to apply.