Job Description
We are seeking an experienced Senior R&D Manager/Director to lead our design, development and verification of next generation medical devices.
The successful candidate will have extensive experience in systems engineering, mechanical and electronic hardware engineering and a strong background in developing medical devices in compliance with applicable FDA and ISO standards and regulations.
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Key Responsibilities
* Manage a multi-disciplinary and multi-site R&D hardware team to develop cutting-edge products.
* Lead and direct system and hardware development activities for innovative 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 the team.
* Ensure compliance with applicable standards and regulations, including FDA requirements, notified bodies, and ISO standards.
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Requirements
* 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 and multi-disciplinary teams across multiple sites.
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Preferred Qualifications
* 10+ years of experience in R&D leadership in the Medical Device Industry.
* Masters degree in Mechanical/Electronic Engineering or related fields.
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About Us
This is a unique opportunity to join a high potential start-up and contribute to the development of next generation medical devices. We offer a dynamic and innovative work environment, opportunities for professional growth and a competitive package.