Job Title: Principal/Sr. Principal R & D Engineer - Neuro-Interventional Products
Location: Shanghai
Job Summary: We are seeking a highly skilled and experienced Principal/Sr. Principal Engineer to lead the design, development, and testing of neuro-interventional products The ideal candidate will possess deep expertise in the medical device industry, particularly in neuro-intervention products, and will be responsible for guiding cross-functional teams through all phases of product development while collaborating with global R&D teams and external partners.
Key Responsibilities:

● Lead the design and development or collaborate with global R&D teams and external partners in co-development of neuro-interventional products from concept through to production, experience in coil and coil delivery systems preferred.
● Work closely with clinical, regulatory, and quality assurance teams to ensure product designs meet all necessary standards and regulations.
● Conduct and provide guidance to external partners thorough testing and validation of prototypes, including bench testing, preclinical studies, and clinical trials.
● Utilize advanced engineering principles and tools to develop innovative solutions for product design challenges.
● Influence product strategy and roadmap by providing insights based on China market trends, competitive analysis, and customer needs.
● Mentor and coach junior engineers, fostering a culture of innovation and collaboration within the team.
● Prepare and review technical documentation, including design history files, engineering reports, and regulatory submissions.
● Participate in user training and presentations to healthcare professionals, ensuring successful product adoption in clinical settings.
● Support new business development activities by conducting technical assessment and oversee the overall product efficacy and safety from design prospective.

Qualifications:

● Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field; Ph.D. preferred.
● Minimum of 10 years of experience in the medical device industry with a focus on neuro-interventional products, specifically coil and coil delivery systems.
● Proven track record in product design, development, and testing, preferably with successful product launches.
● Strong knowledge of relevant regulatory standards (e.g., FDA, ISO 13485).
● Proficient in engineering design software.
● Excellent analytical and problem-solving skills with a keen attention to detail.
● Strong communication and interpersonal skills to collaborate effectively across various stakeholders, including global teams and external partners.
● Ability to lead projects and mentor team members in a dynamic, fast-paced environment.

Preferred Qualifications:

● Experience in imaging systems, delivery systems, or related neuro-interventional technologies.
● Previous experience in a leadership role within a team-oriented environment.

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