Senior RD Engineer, NV

Job Summary:

We are seeking a skilled and experienced Sr RD Engineer to make vital contribution to the design, development and testing of neurointeventional products. The ideal candidate will have good knowledge of neurovascular industry and work with cross-functional teams through all phases of product development while collaborate with global RD team and external partners.

Responsibilities:

· Take part in design and development efforts or collaboration with global RD team and external partners in co-development of neurovascular products from concept through production, experience in neurovascular catheters and stents preferred.

· Work with cross-functional team including clinical, regulatory and quality teams to ensure product designs meet all necessary standards and regulations

· Provide technical support to external partners for testing and validation of prototypes, including bench testing, preclinical study and clinical trials.

· Provide technical support to external partners for troubleshooting of design and process challenges.

· Take part in internal test capability build including development of test fixture or tooling, test method documentation and test method validation

· Conduct internal tests on prototypes from external partners to confirm and evaluate the product performance and support business decision.

· Conduct competitive benchmark testing to support business team for market claim and rebuttal and proof generation.

· Prepare and review tehcnical documentation, including design history file, engineering reports and regulatory submissions

· Provide technical support to new business development activities by conducting technical assessments of the overall product efficacy and safety

Qualifications:

· Master’s degree in Mechanical Engineering, Biomedical Engineering or a related field

· A minimum of 5 years of experience in medical device industry with a focus on neurovascular products, specifically neurovascular catheters and stents

· Proven track record in product design, development and testing of neurovascular products, preferably with successful product launches

· Good knowledge of relevant regulatory standards (e.g. NMPA, FDA, ISO 13485)

· Good grasp of engineering softwares including Minitab and Solidworks

· Demonstrated problem-solving skills

· Good verbal, reading and writing skills of English

· Good communication and interpersonal skills to collaborate effectively across various stakeholders, including global teams and external partners

Preferred Qualifications:

Experience in working for multinational medical device companies

Good Design Six Sigma knowledge including statistical analysis and design of experiments

Good knowledge of GD&T including tolerance stack-up analysis

Other: This position may require 20-30% domestic travel