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.