Medical Device Development Lead
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Our client is seeking an experienced Medical Device Development Lead to drive the development of innovative medical devices. The successful candidate will be responsible for leading system-level design and development, from concept to launch.
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Key Responsibilities:
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* Design and Development: Lead the design and development of medical devices, ensuring compliance with regulatory requirements and industry standards.
* Team Leadership: Manage a team of engineers and designers to achieve project goals and deliver high-quality products.
* Risk Management: Identify and mitigate risks throughout the product lifecycle, ensuring the safe and effective use of medical devices.
* Collaboration: Work closely with cross-functional teams, including clinicians, researchers, and regulatory experts, to ensure that medical devices meet clinical needs and market expectations.
* Quality Assurance: Develop and implement quality assurance processes to ensure that medical devices meet or exceed regulatory requirements.
* Project Management: Plan, coordinate, and execute projects from conception to launch, ensuring timely delivery and within budget.
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Requirements:
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* B.S. or Master's degree in Mechanical Engineering, Biomedical Engineering, or related disciplines.
* 8+ years of experience in medical device development, including leadership roles.
* Experience with FDA, GMP, QSR, and ISO 13485 regulations.
* Excellent communication and leadership skills.
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We offer: A dynamic work environment, opportunities for professional growth and development, and a competitive compensation package.
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